Total 10 Senior Executive affairs manager job vacancies in Ngee Ann Polytechnic, Clementi Campus

Job Description – Senior Regulatory Affairs Executive

• Drafting, compiling and maintaining of technical documents to ensure compliance to the applicable domestic and international regulations and standards , specifically EU MDR 2017/745
• Prepare and submit regulatory technical documentations to regulatory authorities for new registrations, renewal and change notification (eg US FDA, SG HSA, AUS TGA etc)
• Ensure compliance with applicable regulatory requirements and standards for medical device.
• Work closely with internal team for documentation and information gathering.
• Liase with various regulatory authorities and authorised representatives on requirements needed to facilitate product approval and address any deficiencies and queries.
• Support in adverse event reporting, report adverse event regulatory authorities in relevant countries within the stipulated timeline, when required.
• Participate in internal / external audits as part of the audit team (including supplier audit)
• Maintain up-to-date knowledge of regulatory requirements and changes
• Ensure post-market surveillance obligations are complied with regulations
• Any other ad-hoc assigned

Qualification Requirement

• Bachelor’s degree in biological science, biological engineering, pharmacy or related field;
• 4-5 years of experience in medical device regulatory affairs with experience in FDA 510(k) or CE marking
• Familiar with relevant regulatory guidelines and standards such as ISO 13485, EU MDR 2017/745
• Strong attention to detail and organization skills;
• Ability to work independently and as part of a team;
• Strong problem-solving and analytical skills;
• Excellent written and verbal communication skills

Job Description – Regulatory Affairs Executive

· Ensure compliance with applicable regulatory requirements and standards for medical device.

· Assist in the drafting, compiling and maintaining of technical documents to ensure compliance to the applicable domestic and international regulations and standards.

· Prepare and submit regulatory technical documentations to regulatory authorities for new registrations, renewal and change notification.

· Work closely with internal team for documentation and information gathering.

· Liase with various regulatory authorities and authorised representatives on requirements needed to facilitate product approval and address any deficiencies and queries.

· Support in adverse event reporting, report adverse event regulatory authorities in relevant countries within the stipulated timeline, when required.

· Participate in internal / external audits as part of the audit team (including supplier audit)

· Maintain up-to-date knowledge of regulatory requirements and changes

· Ensure post-market surveillance obligations are complied with regulations

· Any other ad-hoc assigned

Qualification Requirement

• Bachelor’s degree in biological science, biological engineering, pharmacy or related field;
• Preferred 2 to 3 years of experience in regulatory affairs within medical device , pharmaceutical or biotechnology industry;
• Familiar with relevant regulatory guidelines and standards eg ISO 13485;
• Strong attention to detail and organization skills;
• Ability to work independently and as part of a team;
• Strong problem-solving and analytical skills;
• Excellent written and verbal communication skills

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, or a related field with at least 2 years of experience.
2. Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices.
3. Expert in medical device product registration laws and regulations, able to independently draft registration dossier.
4. You shall have complete registration experience of Class B, C and D medical devices.
5. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
6. Familiar with IVD product development and commercialization life cycle.
7. Systematically project management, good planning, execution and timely communication. Good presentation skills.
8. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
9. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

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 in Life Sciences, Pharmacy, or a related field
2. Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices.
3. Expert in medical device product registration laws and regulations, able to independently draft registration dossier.
4. You shall have complete registration experience of Class B, C and D medical devices.
5. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
6. Familiar with IVD product development and commercialization life cycle.
7. Systematically project management, good planning, execution and timely communication. Good presentation skills.
8. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
9. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

Interested applicants are invited to apply directly at the NUS Career Portal.

Your application will be processed only if you apply via NUS Career Portal.

Job Purpose

The Institute of Policy Studies (IPS) is a policy research think-tank in the Lee Kuan Yew School of Public Policy, National University of Singapore.

IPS is looking to hire, on a two-year contract, an Executive for its Public Affairs team. The executive will be responsible for creating design artwork for the department.

This will be a great opportunity for anyone interested in public and government relations. The job offers a rare and deep immersion into the details of policy planning and governance.

Job Description

• To design artwork for promotion of IPS events.
• To conceptualise infographics and other content for promotion of IPS research and podcasts.
• To design book covers and other publication materials.
• Assist to develop content strategy and meaningful content to engage stakeholders through social media engagement and website
• Assist in reporting to stakeholders
• Produce IPS collaterals and manage vendors
• Upholding of editorial governance such that content is consistent with the Institute’s brand voice, style and tone

Qualifications

• Proven graphic designing experience
• Strong portfolio of illustration and other graphics
• Degree in Design, Fine Arts or related field is a plus
• Familiarity with design software and technologies (such as InDesign, Illustrator, Dreamweaver, Photoshop)
• Possess knowledge of motion graphic and video editing skills.
• HTML knowledge a plus.
• Working knowledge of social media platforms
• A keen eye for aesthetics and details
• Highly motivated, resourceful, meticulous and able to multi-task
• Possess strong tenacity, flexibility and resourcefulness to clear roadblocks and maturity to manage stakeholders, external agencies and partner
• Ability to work methodically and meet deadliness

To Apply

Please upload your cover letter and curriculum vitae via NUS Career Page.

Your CV should include details such as your highest qualifications, last drawn salary, expected salary and reasons for leaving your last/current position. Please also state when you expect to be able to begin work if this position is offered to you.

(We thank all applicants for their interest; however, only shortlisted candidates will be contacted for an interview.)

Interested applicants are invited to apply directly at the NUS Career Portal.

Your application will be processed only if you apply via NUS Career Portal.

We regret that only shortlisted candidates will be notified.

Job Purpose

The role will be supporting the Public Affairs team and responsible for social media content creation, managing media relations, public engagement and stakeholder reporting.

Job Description

The Executive will be responsible in social media content creation, managing media relations, public engagement and stakeholder reporting.

Qualifications

• Possess a good Bachelor Degree, preferably in Mass Communication/Marketing
• Possess at least 1 year of relevant working experience in corporate communication, marketing or media/public relations
• Strong interest in public policy and current affairs
• Possess writing and copyediting ability
• Working knowledge of image editing and video editing for social media platforms
• Possess knowledge of social media platforms, ad buys and analytics
• Possess an editorial mindset and understand social media audience

Job Description
Yale-NUS College is a highly selective liberal arts and science college in Singapore. Co-founded by Yale University and the National University of Singapore, the College is committed to excellence in research and teaching within a full residential programme that integrates living and learning. Its curriculum educates students in Asian and Western intellectual traditions as well as current scientific thought.

In order to enhance the research and teaching environment of the College, we welcome senior scholars to spend one or two semesters on our campus. The visiting faculty will be actively involved in research, preferably in cognate research areas with Yale-NUS faculty research fields, and will be asked to teach one or two courses per semester of their visit. We are currently seeking a Visiting Senior Lecturer to teach two (2) courses in Semester 1 of Academic Year 2024-2025.

Candidates should have a PhD degree with an excellent track record in research related to Global Affairs. Research achievements should include publications in leading peer-reviewed journal or conference commensurate with career stage

Job Requirements
Extensive teaching experience and passion for undergraduate education is essential.

Application Procedures
Applications should consist of the following: a cover letter explaining why the position at Yale-NUS is of interest; a full curriculum vitae, including a complete list of publications; statement on research interests, teaching experience and teaching philosophy, including how these might fit with the College’s particular mission and curriculum and other relevant documents.

We regret that only shortlisted candidates will be notified.

Equal Opportunity Employer
Yale-NUS College achieves excellence through the diversity of its students, faculty, and staff and by embracing inclusivity, equity, and global engagement. We encourage applications by diverse individuals with a demonstrated commitment to these values. For more information about the College, please visit https://www.yale-nus.edu.sg

Personal Data Protection Act (PDPA)
Candidates should understand that by sharing information with Yale-NUS, they authorise the College to use their personal data for the purposes of this application. The College will not use their data for other purposes and ensure that their data remains secure and confidential.

Benefits & Highlights:

• Work Style: Hybrid/Flex
• Location: Buona Vista
• Great employee benefit
• Weekly office lunches
• Reporting Line: Regulatory Manager, APAC

About the Role :-

This role will advance Regulatory Affairs (RA) functions by planning and driving initiatives focused on continuous improvements and operational excellence of regulatory systems and processes, as well as creating and maintaining mechanisms for rapid tactical execution of regulatory tasks. With a strong focus on Regulatory Information Management and Analysis, playing a key role in aligning processes and facilitating the effective execution of regulatory related activities; helping to ensure the right level of cross-functional transparency and accountability through the regulatory process.

• Supporting, and at times, driving the initiative for the effective implementation of a Global Regulatory Information Management System (RIMS) within APAC to facilitate the centralisation of common documentation in support of global registration activities and processes.
• Supporting business needs by liaising with internal partners, Regulatory team, IT, and vendors to identify technical solutions and for translating RA processes into executable workflows
• Maintaining traceability from RA information through the decision-making process into materialised outputs
• Anticipating regulatory or related obstacles and emerging issues throughout the product lifecycle, leveraging and developing a mechanism for regular review and associated actions
• In accordance with evolving regulatory requirements and trends, participating, and at times, driving system and process improvement projects, including but not limited to new regulatory policies, processes and SOPs, ensuring appropriate collaboration with stakeholders.

Education and Experience:

• Degree qualified preferably in a Science or Engineering discipline.
• Training in technical operational aspects of Regulatory Affairs, with at least 3 years of direct Regulatory Affairs experience within a medical device company preferably with Orthopaedics
• Able to work independently as well as part of a cross-functional team, with exceptional written and oral communication skills and the ability to successfully build effective working relationship.
• Regulatory Affairs Certification (RAC) an added bonus
• Ability to read and comprehend scientific literature to collect data, establish facts, draw valid conclusions and produce scientifically supported documentation.
• Experience with MS Office as well as SAP

About Arthrex

Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.

Benefits & Highlights:

• Work Style: Hybrid/Flex
• Location: Buona Vista
• Great employee benefit
• Weekly office lunches
• Reporting Line: Regulatory Manager, APAC

About the Role :-

Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements. Staying abreast with regulatory compliance requirements and changes affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions.

• Writing, preparing, submitting regulatory documents for the South-East Asia (SEA) market (Arthrex distributor and subsidiary)
• Prioritising and organising multiples projects with competing priorities
• Participating in regulatory affairs planning for SEA markets
• Providing support in APAC level projects as and when needed
• Regularly maintaining and updating product registration and listing databases for the assigned country
• Implementing change control for already-approved products including regulatory submissions
• Keeping abreast with the latest regulatory updates within SEA relating to Arthrex products and ensuring Arthrex as a company is aware, ready and able to comply with the necessary changes
• Providing input to change management projects for global regulatory change assessments
• Participating and providing support in cross-functional collaboration on new product and country launches
• Assisting in activities relating to post market surveillance (i.e. Complaints, Performance Evaluation Reporting (PER), Adverse Event Reporting (AER), and/or liaising with Regulatory bodies in assigned countries)
• Participating in both internal and external quality system audits

Education and Experience:

• Degree qualified preferably in a Science or Engineering discipline
• Minimum 4-5 years direct RA experience within a medical device company
• Strong working knowledge of SEA medical device regulations and standards
• Knowledge of global regulations will be advantageous
• Excellent interpersonal skills, with proven ability to effectively communicate and form strong relationships with stakeholders across all levels
• Ability to work in fast paced environment and handle multiple tasks and requests
• Comprehension of technical, engineering or medical terminology, and/or ability to reference literature for understanding
• Technical skills in manufacturing or design relating to regulatory affairs will be advantageous

About Arthrex

Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.

COMPANY DESCRIPTION

Mediacorp is Singapore’s largest content creator and national media network, operating a suite of TV channels, radio stations, and multiple digital platforms. Its mission is to engage, entertain, and enrich audiences by harnessing the power of creativity.

We are committed to creating an inclusive and diverse workplace where talent thrives. Our hiring decisions are made based on merit and fit-to-role. If you have a disability or special need which requires accommodation to participate in the recruitment process, please inform us when you submit your online application. We will be happy to support as necessary.

Thank you for your interest and application to this role. Please note that only short-listed candidates will be contacted.

RESPONSIBILITIES

Responsibilities:

• The team at TNCA produces content for radio, TV and digital/social platforms.
• As a Senior Producer, you will be responsible for producing and overseeing the content for the radio and TV bulletins.
• Based on your experience, you would handle any of the specific roles on a given day: radio line producer; TV line producer or vetter.
• As a radio line producer, you would copytaste, write and compile the daily radio bulletins. As a TV line producer, you would oversee the production of the daily TV bulletin as well manage the team that produces this.
• As a vetter, you would be vetting the stories written by reporters and producers across all platforms.
• This role requires a seasoned journalist/producer who has a keen news sense and bilingual competency.
• You must uphold and maintain the expected standards pertaining to accuracy, objectivity and timelines.
• You must understand the role of Tamil News within the larger community.
• Connections with key personalities and newsmakers within the Indian/Tamil-speaking community are valuable assets for this position.
• You need to be a team player as your role requires close coordination with your newsroom colleagues as well as colleagues from other departments across Mediacorp.
• You may also be involved in projects and duties assigned by the Chief Editor.

Requirements:

• Good University Degree preferably in Mass Communication or related fields.
• At least 5-7 years of experience in a related field.
• Have a good command of Tamil, both written and spoken for business purpose.
• Have a strong interest in local and international news and current affairs.
• A dynamic individual who is a team player with good communications skill.
• Be prepared to work irregular hours, public holidays and weekends.
• Possess tactful communication and interpersonal skills.
• Be creative and independent.