• Regulatory Affairs Executive with global pharmaceutical company
• Great work culture
• Competitive Remuneration

An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Executive to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.

As the RA Executive, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.

You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is a requirement.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

• Regulatory Affairs Pharmacist with global pharmaceutical company
• Great work culture
• Competitive Remuneration

An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Pharmacist to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.

As the RA Pharmacist, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.

You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is a requirement.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

General Responsibilities

Local Product Registration

o Prepare and submit product registration documentation and other relevant licences’ application

o Ensure and maintain product approvals and licenses where applicable

o Perform regulatory assessment and clearance to order blockage related to regulatory matters

o Support business partners in new product registration, re-registration, renewal and amendment

o Support Sales, Marketing and regulatory related areas

Regional Product Registration

o Maintain product registration records and databases to ensure proper documentation and record filing

o Maintain the knowledge and awareness of current applicable regulations and standards

o Support business partners in new product registration, renewals and amendments

o Support Sales, Marketing and all regulatory related areas

o Assisting the operational tasks as required

Job Requirements:

· BSc in Medical Science or equivalent

· Min 1 years’ experience in regulatory affairs including regulation research, technical documents creation and regulatory submissions.

Interested candidates please send in your resume to:

[email protected]

EA Personnel: Valerie Yong Kian Fung

CEI No.: R1103704

Recruit Express Pte Ltd, EA License No.: 99C4599

Job Scope:

• To prepare dossier & product registration submissions for timely introduction of new products and responsible for supplemental filings for any changes.

• To in data/information gathering & dossier compilation for product registration submission & other related licenses for affiliates & distributors including progress monitoring & follow-ups.

• To provide regulatory support, update, advisory & knowledge sharing with, 3rd party manufacturers & other manufacturers and to affiliates & distributors in order to remain in compliance with the government regulatory requirements in Asia Pacific.

Job Requirements:

• BSc in Medical Science or equivalent

• Min 1 years’ experience in regulatory affairs including regulation research, technical documents creation and regulatory submissions.

Interested candidates please send in your resume to:

[email protected]

EA Personnel: Valerie Yong Kian Fung

CEI No.: R1103704

Recruit Express Pte Ltd, EA License No.: 99C4599

• Regulatory Affairs Executive with global pharmaceutical company
• Great work culture
• Competitive Remuneration

An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Executive to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.

As the RA Executive, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.

You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is a requirement.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

• Regulatory Affairs Pharmacist with global pharmaceutical company
• Great work culture
• Competitive Remuneration

An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Executive to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.

As the RA Pharmacist, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.

You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is a requirement.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

• Regulatory Affairs Pharmacist with global pharmaceutical company
• Great work culture
• Competitive Remuneration

An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Executive to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.

As the RA Pharmacist, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.

You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is a requirement.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

Medical Affairs Manager/Director - Biopharmaceutical

Role Summary

We are seeking an experienced Medical Affairs profile to lead our medical affairs initiatives across Southeast Asia. This senior role involves driving regional strategies, building relationships with healthcare professionals, leading the medical science liaisons (MSL’s) and serving as a key representative in advancing scientific and medical excellence. You will be responsible to align local medical plans with global objectives to support the organisation’s mission for 2025 and beyond.

The Opportunity

This position offers the chance to make a meaningful impact on healthcare in the region. You will:

• Develop and execute medical affairs strategies that align with global goals.
• Lead a team of MSLs, supporting their growth and optimising performance.
• Build relationships with thought leaders and the broader medical community.
• Plan and oversee scientific events, including advisory boards, webinars, and symposiums.
• Represent the organisation at regional and global medical affairs meetings and conferences.
• Drive regional research initiatives, such as investigator-sponsored studies and educational grants.
• Collaborate with regulatory, market access, and patient advocacy teams to address country-specific needs.
• Ensure compliance with regulations while managing budgets effectively.

What We’re Looking For

• A degree in Biology, Biotechnology, Pharmacy, or Medicine; a PhD, MD, or similar is highly desirable.
• 7 – 12+ years of experience in medical affairs, preferably within the pharmaceutical or biopharmaceutical industry.
• Advanced knowledge of medical and pharmaceutical sciences, coupled with ethical and scientific integrity.
• Strategic thinking, relationship-building, and communication expertise.

What’s on Offer

• Competitive salary - ranges depending on experience
• Benefits package
• International team
• Improving patient outcomes and advancing healthcare innovation

What’s Next

If this opportunity excites you and aligns with your expertise, we encourage you to apply.

Send your updated CV to [email protected]highlighting your relevant experience. We look forward to exploring how your expertise can contribute to transforming healthcare in the region.

Please note: Due to high application volumes, we may not be able to respond to every applicant. If you do not hear from us, please consider your application unsuccessful at this time. We encourage you to apply again in the future.

Engage Group Life Science – Singapore & Southeast Asia
[email protected]

• Regulatory Affairs Associate with global Medical Device MNC
• Opportunity to work on local and regional submissions

Partnering with a global Medical Device MNC with an established branding, our client is seeking a Regulatory Affairs & Quality Assurance Executive (6-Months Contract).

Reporting to the RA/QA Director, we are looking for someone with good knowledge of regulatory framework.

In this role, you shall assist in the execution of the regulatory strategies in assigned markets throughout the company product life cycle, with a focus on efficient pre-market and post- market regulatory approvals.

You will also support the review and approval of:

• Change control activities
• Product promotional activities
• Product registration
• Product labeling
• Regulatory inspections and audits

You should have at least 2 years’ of regulatory experience in medical devices and a related science degree.

For more information, please apply with your updated CV (in Word document).

Ambrose Chan

Registration Number: R1218177
EA License Number: 17C8502

Salary: up to $2700

Working Days & Hours: Mon-Fri Office Hours

Location: Novena

Job Scope:

• Serve as primary coverage for educational contact person for the postgraduate programme.
• Assist and support the administration of Postgraduate Training Programmes.
• Assist and support the administration of medical seminars and workshops.
• Plan and administer programme onboarding, and orientation.
• Track all evaluations, monitor, and document compliance.
• Maintain documentation of all training records.

Job Requirements:

• Min Diploma in any relevant field preferably in healthcare

For interested applicants, please send your updated resume to: [email protected]
All candidates’ information will be treated with the strictest confidence
Melissa Zhang Zhiqi (Mezzo)
R2197564
Recruit Express Pte Ltd
99C4599

Job Responsibilities

1. Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
2. Be the subject matter expert on medical devices laws and regulations for product registration in company’s regions of interest.
3. Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process.
4. Involve in the process of product testing, clinical verification, data collection and relevant tracking.
5. Submit to agencies scientific special projects on behalf of the company.
6. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
8. Any other ad-hoc duties or projects as required by the management team.

Job Qualifications:

1. A bachelor's degree in Life Sciences, Pharmacy, Biotechnology or a related field
2. Systematically project management, good planning, execution and timely communication. Good presentation skills.
3. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
4. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

Key Job Purpose:

• Dossier preparation & product registration submissions to HSA, leading to timely introduction of new products and responsible for supplemental filings for any changes.
• Assisting in data/information gathering & dossier compilation for product registration submission & other related licenses for SAP affiliates & distributors including progress monitoring & follow-ups.
• Provide regulatory support, update, advisory & knowledge sharing to S-Corp, 3rd party manufacturers & other manufacturers and to Sysmex affiliates & distributors in order to remain in compliance with the government regulatory requirements in Asia Pacific.

Job Responsibilities:

1. Product Registration (Local):

• Prepare & submit product registration documentation & other relevant licences’ application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Singapore
• Review and edit dossier to comply with regulatory requirements
• Notify and update Health Sciences Authority (HSA) of any change of particulars / documents related to product registration
• Ensure changes to the approved products are timely submitted to authorities as required
• Ensure and maintain product approvals and licenses, including dealers etc. where applicable
• Manage Adverse Event and Field Safety Corrective Action reporting to HSA within the stipulated timeline
• Maintain product registration record and product registration database in iConnect to ensure proper documentation and record filing
• Maintain registration information in RA modules in S4& GTS and perform regulatory assessment and clearance to order blockage related to regulatory matters.
• Maintain the knowledge and awareness of current applicable regulations and standards and industry guidance in Singapore that impact the company’s compliance
• Support business partners in new product registration, re-registration, renewal and amendment
• Support Sales, Marketing and SCM in all regulatory related areas
• Assisting the operational tasks as required

2. Product Registration (Regional)

• Assisting the AP affiliates & distributors in data/information gathering from manufacturers, drafting/assisting in preparation of initial dossiers for submission
• Maintain product registration records and product registration databases to ensure proper documentation and record filing for all affiliates and business partners countries
• Maintain the knowledge and awareness of current applicable regulations and standards for all affiliates and business partner countries
• Support business partners in new product registration, renewals and amendments
• Support Sales & Marketing and SCM in all regulatory related areas
• Assisting the operational tasks as required

Job Requirements:

• BSc in Medical Science or equivalent
• Min 1 years’ experience in regulatory affairs including regulation research, technical documents creation and regulatory submissions.
• Medical Device Act & other medical device related regulations in Asia Pacific countries
• Fluent in English
• Knowledge of major IVD regulations/standards, at least IVD-R, ISO13485, MDSAP
• Basic computer knowledge & application, e.g. Microsoft Office, Power PDF, etc

• Regulatory Affairs Executive with global pharmaceutical company
• Great work culture
• Competitive Remuneration

An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Executive to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.

As the RA Executive, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.

You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is a requirement.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

• Regulatory Affairs Pharmacist with global pharmaceutical company
• Great work culture
• Competitive Remuneration

An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Pharmacist to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.

As the RA Pharmacist, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.

You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is a requirement.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

Responsibilities

Quality Assurance:

• Overall implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR 820 standards.
• Ensure all departments carry out due processes and documentation required to ensure conformance to the QMS, including design & development, production and software.
• Conduct internal audits and lead external audit preparations.
• Conduct Management Review, onboarding training for new employees, and company-wide refresher training
• Collaborate with cross-functional teams to address non-conformances, CAPAs, and continuous improvement initiatives.
• Participate in risk analysis and management activities to ensure compliance with ISO 14971.
• Support post-market surveillance and vigilance reporting activities.

Regulatory Affairs:

• Preparation, submission, and maintenance of regulatory documentation for market approvals in regions including Singapore, US, Malaysia, and Australia.
• Monitor and interpret regulatory updates and standards relevant to medical devices.
• Ensure labeling, packaging, and promotional materials comply with regulatory requirements.
• Collaborate with the R&D and manufacturing teams to ensure product compliance during development and production phases.
• Maintain accurate and organized records to support regulatory inspections and audits.

Minimum Skills and Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• Ability to work independently and cross-functionally with different teams
• Strong organizational and analytical skills.
• Effective communication and teamwork abilities.

Advantageous Skills

• Knowledge or experience with regulatory submissions to Malaysia MDA, Australia TGA, US FDA, and Singapore HSA.
• Familiarity with ISO 13485, ISO 14971, and other relevant standards.

• Location: West
• Faculty Development: Manage faculty development initiatives and track performance with the Associate Chair (Faculty).
• Faculty Recruitment: Oversee tenure-track and tenured faculty recruitment, planning outreach and candidate identification.
• Faculty Appointments: Manage non-tenure track faculty appointments and re-appointments, handling the entire process.
• Performance Appraisal: Coordinate and oversee the annual faculty performance appraisal, ensuring timely completion and policy adherence.
• Promotion & Tenure: Lead and manage the faculty promotion and tenure process, ensuring compliance with policies.
• Fellowship Recruitment: Oversee the Fellowship recruitment process.
• Award Nominations: Assist in nominating faculty for local and international awards in collaboration with the Associate Chair and School Chair.
• LinkedIn Recruitment: Manage LinkedIn Recruiter platform to source candidates for faculty and research staff positions.
• Secretariat Role: Serve as the secretariat for major school meetings and discussions.

Interested applicants may email resume to [email protected]

Jessie Hoe Huey Miin (CEI Registration No: R1103861)

Recruit Express Pte Ltd (EA: 99C4599)

Responsibilities :

• To execute risk management plans for medico-legal cases and clinical complaints to ensure effective resolution for the organization.
• To undertake specific tasks or projects promoting good clinical care in the hospital.
• Manage medico-legal cases and clinical complaints to ensure effective resolution
• Manage claims process and coordinate the renewal and administration of medical malpractice coverage for the organization
• Drive the ML education and communication arm to increase awareness of the latest industry trends and issues
• Serve as a Secretariat to the Clinical Care Review Committee (CCRC)
• Manage ad hoc projects

Requirement :

• Degree in Nursing or equivalent
• Experience in case handling
• Keen to move to a corporate role

If you are interested in the position, do kindly drop your most updated resume to [email protected]

Kailey Lee Jia Yueh

EA Personnel No: R24126040

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Job title – Lead Specialist, Health Nutrition & Care

Location – APAC

Job model – Hybrid

As a Regulatory Affairs Lead Specialist, you will be responsible for APAC regulatory review, ingredient/ product registration and maintenance of compliance database for the Dietary Supplement (DS) and Market Ready Solution (MRS) divisions of Health, Nutrition & Care (HNC) Business Unit (BU). You will also advise/ provide recommendations to Marketing and Sales, Product Management, Supply Chain, and Purchasing in all regulatory-related matters. You will render regulatory-specific support to marketing and sales for customer-related activities, including customer presentations/ workshops, customer enquiries, alignment of customer quality agreements and specifications sign-off.

At dsm-firmenich, people are at the heart of the company. We are committed to equal employment opportunities and value diversity in the workplace.

Your key responsibilities

• Conduct RA compliance reviews of dsm-firmenich’s products, proactive monitoring of changes in regulatory environment along with impact analysis and ensuring these activities are updated in the RA compliance database in a timely manner.
• Responsible to address customer enquiries according to timelines specified in the Service Level Agreement.
• Manage dossier preparation ingredient/ product approvals in collaboration with Global or Regional Regulatory Affairs, Regional Business, Project Management, R&D functions, consultants etc. based on company strategy.
• Submit dossiers to the local authorities, follow up on the approval process closely with evaluators and communicate progress in a timely manner to internal stakeholders.
• Ability to conduct regulatory risk assessments, propose mitigation plans/ recommendations and contribute to process improvement activities, as needed.
• Effectively prioritise and negotiate deliverables/ tasks in an agile and dynamic environment.

You bring

• Minimum Bachelor’s degree in Pharmacy, Nutritional Science, Food Science or related disciplines
• Minimum 8 years of experience in regulatory affairs in food, food supplement and pharmaceuticals.
• Demonstrated collaborative and influencing skills with internal colleagues, customers and relevant authorities across different functions and regions.
• Basic digital skills required (Microsoft Excel, PowerPoint, PowerBI, etc.)
• Ability to work effectively under pressure and in a matrix and dynamic organization.
• This is a 1-year contract position.

We bring

• A rich history and a promising future of bold scientific innovation and passionate creation with our customers;
• A space to grow by encouraging and supporting curiosity and an open mindset;
• A culture that prioritizes safety and well-being, both physically and mentally;
• The opportunity to work for a company where sustainability is much more than a claim and is core to our strategy and purpose;
• A flexible work environment that empowers people to take accountability for their work and own the outcome;
• Barrier-free communities within our organization where every employee is equally valued and respected – regardless of their background, beliefs, or identity;

Equal Opportunities Commitment

dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate, there’s a place for everyone at dsm-firmenich.

dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. dsm-firmenich people are as diverse as our customers. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.

We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.

About dsm-firmenich

As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.

www.dsm-firmenich.com

- To execute risk management plans for medico-legal cases and clinical complaints so as to ensure effective resolution for the organization.

- To undertake specific tasks or projects that will promote good clinical care in the hospital.

- Manage medico-legal cases and clinical complaints to ensure effective resolution

Interested applicants please email a copy of your resume to [email protected]

Tele @jesswongie OR WA 96503173

Jessie Wong Yuan Si

Personnel EA License No.: R2197171

Recruit Express Pte Ltd (EA Licence No.: 99C4599)

About the role

We are seeking a Temporary Executive (Academic Affairs) to join the National Institute of Early Childhood Development (NIEC) in the West Region on a 7-month contract to cover a maternity leave. In this role, you play a key part in supporting the implementation of academic governance policies and examination-related processes, and providing secretariat support for NIEC Board of Examiners (BOE) meetings.

What you'll be doing

• Issue electronic copy of academic collaterals, print and issue physical copies to NIEC graduates
• Implement academic governance policies and examination-related processes, monitor and rectify any gaps or inconsistencies
• Provide secretariat support for NIEC BOE meetings
• Generate, analyse and exchange data with internal and external stakeholders for planning, reporting and sharing purposes

What we're looking for

• A Bachelor’s degree in any discipline
• Preferably with relevant work experience in Registrar’s Office or Academic Affairs Office
• Knowledge in examination-related processes
• Strong communication and interpersonal skills with the ability to liaise effectively with diverse stakeholders
• Excellent organisational and project management skills with the ability to prioritise and multitask
• IT savvy and proficient in Microsoft Word, Powerpoint and Excel
• High attention to detail, strong analytical, critical thinking and problem-solving skills
• Able to start immediately

• Senior / Regulatory Affairs Associate with global Medical Device MNC
• Opportunity to work on local and regional submissions

Partnering with a global Medical Device MNC with an established branding, our client is seeking a Senior/ Regulatory Affairs & Quality Assurance Executive.

Reporting to the RA/QA Director, we are looking for someone with good knowledge of regulatory framework.

In this role, you shall assist in the execution of the regulatory strategies in assigned markets throughout the company product life cycle, with a focus on efficient pre-market and post- market regulatory approvals.

You will also support the review and approval of:

• Change control activities
• Product promotional activities
• Product registration
• Product labeling
• Regulatory inspections and audits

You should have at least 2 years’ of regulatory experience in medical devices and a related science degree.

Candidates with more experience will be considered for a 'Senior Executive' role.

For more information, please apply with your updated CV (in Word document).

Ambrose Chan

Registration Number: R1218177
EA License Number: 17C8502

About Us

Vivo Surgical is a patient-focused, clinician-driven medical device developer and manufacturer. Headquartered in Singapore with offices in China and Thailand, we are pioneering a novel endoscopic surgical robot for complex endoluminal surgeries. ISO 13485 certified with international accreditations awarded such as the US FDA and European CE mark, our devices target the medical needs of the world through innovative applications of science & technology. These encompass such fields as in vivo surgical LED lighting, portable endoscopy and endoscopic robots, which are strategically co-developed with world-class healthcare institutions and KOL collaborators. Join us as we build towards our vision of being Asia Pacific’s leading medical device developer and manufacturer.

About The Role

We value the importance of having a robust Quality Assurance and Regulatory Affairs team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Quality Assurance & Regulatory Affairs Manager to join us on this journey. You will be part of our fast-growing team and will take ownership of your role from the get-go. You will work on ensuring our company’s commitment to comply with regulatory requirements and to maintain the effectiveness of our Quality Management System (QMS). You will also be in charge of our products’ regulatory strategies and submissions to various regulatory bodies. Your role will enable you to work not only with diverse functions internally but also in close tandem with our external partners such as our suppliers, distributors and notified bodies.

Your responsibilities shall include the following:

• Ensure the company’s QMS complies with ISO 13485 and FDA 21 CFR 820/QMSR.
• Develop and manage Quality Procedures such as document control, CAPA, NCR, Supplier Control, Production Control, Feedback and Complaints Handling, and Post Market Surveillance.
• Organize and execute internal audits, management reviews and supplier audits.
• Plan and lead ISO 13485 audits and regulatory inspections.
• Participate in the products’ verification and validation activities.
• Develop, review and compile the medical device technical files whilst making sure the products meet all regulatory and quality standards.
• Involved in risk assessment tasks to identify potential quality and compliance risks in the product lifecycle and advise adequate risk control measures.
• Serve as the company’s Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC).
• Manage and mentor the QARA team to ensure members are adequately trained.
• Stay updated on medical device laws and regulations in the targeted markets.
• Work with senior management to define and deliver adequate quality and regulatory strategies.

Your Qualifications & Experience

• Minimum Bachelor’s degree in Engineering or Science.
• At least 5 years’ experience in quality assurance and/or regulatory affairs in the medical device Industry.
• Firm understanding of ISO 13485:2016, FDA 21 CFR 820/QMSR and ISO 14971.
• Prior involvement in HSA, FDA 510(k)/De Novo and/or MDR 2017/745 submissions will be a plus.
• Experience in generating risk management documentation (risk management plan, report, FMEAs).
• Possess a leadership and strategic mindset to organize and prioritize tasks for effective and timely delivery of regulatory goals to meet the company’s business objectives.
• Certification as an ISO13485:2016 lead auditor will be advantageous.

Contact

Please send your CV and cover letter to: [email protected]. We look forward to receiving your application.

• Stay updated on regulatory changes and assess their impact on the business and products.
• Communicate updates on HSA and APAC regulations to regional/global RA and commercial teams.
• Develop registration strategies, timelines, and risk mitigation plans for assigned products/projects.
• Manage new product submissions, lifecycle variations, and cross-functional collaboration to meet regulatory requirements.
• Prepare and maintain local SOPs and policies in line with global and local regulations.
• Provide regulatory support for marketing plans, product launches, and promotional material reviews to ensure compliance.
• Maintain strong relationships and negotiate with the Health Sciences Authority (HSA) to secure timely approvals.
• Represent APAC RA in project teams and address regulatory agency queries.
• Ensure accuracy and quality of regulatory documentation and strategic submissions.
• Monitor project progress, identify delays, and recommend improvements to accelerate timelines.

Job Requirements:

• A bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related field
• Minimum of 5 years of regulatory experience in the pharmaceutical industry, covering OTC, health supplements, pharmaceuticals, and vaccines.
• Must be a Singapore-registered Pharmacist with access to PRISM (HSA online system).
• Regional regulatory affairs (RA) experience or exposure is highly desirable.
• Strong strategic and conceptual thinking skills, with an entrepreneurial mindset and the ability to prioritize effectively.
• Demonstrates agility, initiative, integrity, and the ability to anticipate potential issues, coupled with proposing mitigation strategies.
• Meticulous with attention to detail and capable of navigating ambiguities.
• Proven leadership skills and experience working collaboratively across functions, levels, and managing projects.
• Proficiency in English, both spoken and written, with the ability to communicate effectively with all management levels and across diverse cultural backgrounds.
• Comprehensive knowledge of local and APAC regulations.
• Excellent interpersonal, communication, and negotiation abilities.

Location : Bugis

Interested applicants please send your resume to [email protected]

We regret that only short-listed candidates will be notified.

PERSOLKELLY Singapore Pte Ltd EA License No. 01C4394 I RCB No. 200007268E EA Reg. No. R1107631

By sending us your personal data and CV, you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for account creation in GO and the purposes set out in the Privacy Policy https://www.persolkelly.com.sg/policies. You acknowledge that you have read, understood, and agree with GO’s Terms of Use https://go.persolkelly.com/Tac and the Privacy Policy. If you wish to withdraw your consent, please email us at [email protected]. Please feel free to contact us if you have any queries

Responsibilities :

• To execute risk management plans for medico-legal cases and clinical complaints to ensure effective resolution for the organization.
• To undertake specific tasks or projects promoting good clinical care in the hospital.
• Manage medico-legal cases and clinical complaints to ensure effective resolution
• Manage claims process and coordinate the renewal and administration of medical malpractice coverage for the organization
• Drive the ML education and communication arm to increase awareness of the latest industry trends and issues
• Serve as a Secretariat to the Clinical Care Review Committee (CCRC)
• Manage ad hoc projects

Requirement :

• Degree in Nursing or equivalent
• Experience in case handling
• Keen to move to a corporate role

If you are interested in the position, do kindly drop your most updated resume to [email protected]

Kailey Lee Jia Yueh

EA Personnel No: R24126040

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for three consecutive years (2021, 2022, 2023).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

A Therapy Area Specialist role, an in-field marketing role, excels in disease and brand knowledge to enable in-depth discussion with healthcare professionals (HCP specialist for example Oncologists, Surgeons) and supports therapy area strategy development & execution in close collaboration with oncology cross-functional team

WHAT YOU WILL DO (it is included but not limited as below mentioned):

Customer Engagement

• Demonstrate in-depth disease, treatment, indication and brand knowledge (including patient pathway, stakeholder mapping) to enable impactful discussion with customers on demand, ensuring service standard are met based on HQ guideline
• Communicate the latest scientific updates within label for both company and competitor products with customers to enable them to make informed decisions about treatment choices
• Facilitate speaker programs; organizes local physician groups for peer-to-peer product education and clinical experience with HCPs
• Provide education to other healthcare stakeholders (e.g. nurses)
• Collaborate closely with cross-functional teams in customer engagement to ensure customer’s scientific needs are addressed timely
• Provide in depth discussion and maintain high engagement level with a list of HCPs under his/her responsibility.

Marketing execution and strategy support

• Document and provide customer insights to cross-functional teams and contribute to key decision maker identification & mapping and brand strategy development
• Develop promotional material development leveraging customer insights gained through customer interactions
• Create contents for local and international conferences, forums, speaker programs etc. (on-label information only)
• Support marketing tactic planning and execution in alignment with brand strategy (event planning, etc.)

Other internal support

• Provide regular internal disease, treatment, indication training to cross-functional team and onboard new customer facing members
• Provide post scientific conference update and training to internal team members for in market indications.
• Contribute to development & execution of account plans in collaboration with cross functional team to deliver impactful strategies that accelerate value for company

WHAT YOU MUST HAVE

• University pharmacy degree or an advanced degree in Life science
• 4 or more years' experience working with HCPs, ideally representing multiple products and working across a complex healthcare system environment
• Good understanding of healthcare environment trends
• Understanding of industry legal, regulatory and compliance landscape
• Ability to assimilate and communicate complex clinical and product information to broad audience of different level of technical expertise
• Experience in building long term customer relationships and advocacy development
• Ability to coach, train, and mentor customer facing team
• Ability to seek out relevant information, prioritize, and apply information to solve complex problems in the ecosystem in a timely manner
• Ability to work in a cross-functional environment and able to collaborate with other team members to provide best support to customers

WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in Pharmaceutical Manufacturing.
• A state-of-the-art facility that delivers solution to its customers world-wide
• Highly engaging team that aims to innovate the future
• Chance to work above site functions, project management exposure and be part of continuous project improvement plan.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.