Total 8 job vacancies by Integrity Partners Pte. Ltd.

• Regulatory Affairs & Quality Assurance Executive 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

• Regulatory Affairs & Quality Assurance Executive 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

• Regulatory Affairs & Quality Assurance Executive 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

• Regulatory Affairs & Quality Assurance Executive 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

I am presently representing a company in their search for a Quality Assurance Leader to bolster their ambitious business expansion endeavors. The selected candidate will be entrusted with spearheading a team of QA professionals to bolster the company's achievements and successes.

MAIN RESPONSIBILITIES

1. Team Leadership:

• Strategizing, leading, and overseeing the operations of the QA group.
• Fostering a collaborative relationship between QA team members and other functional departments achieve business success
• Oversee the productivity of the QA team and develop tailored progression plans for QA executives.

2. Driving change and transformation:

• Directing the regional quality operations team, ensuring its pivotal role in meeting business goals through a risk-oriented and efficient manner.
• Identifying ongoing enhancement prospects throughout the QMS and setting clear objectives for the regional QA team.

3. Collaboration and Stakeholder Engagement:

• Ensure effective cross-functional collaboration to fulfill quality needs for assigned regions.
• Partnering with diverse functional leaders to effectively drive business outcomes.

4. Operational Success

• Oversee new product introduction and supplier qualification/management, ensuring continued quality compliance of partners.
• Maintainence of Quality Management Systems and ensuring up-to-date compliance in accordance to relevant guidelines, regulatation and company policies.
• Ensure batch release/change controls/deviations/CAPA management/recall activities are being managed timely and effectively.

To apply, submit your most updated resume showcasing relevant qualifications and experience.

Requirements

• Bachelor's degree in Science or a related field.
• Minimum of 12-15 years' experience in the life science industry (such as pharmaceuticals, medical devices, and health supplements) within the quality function, demonstrating robust technical expertise in GxP.
• Proven experience in leading teams and driving quality improvement initiatives.
• Possession of strong business acumen, adept problem-solving skills, effective communication abilities, and adept stakeholder management capabilities are essential attributes for this role.

Not the right opportunity?

We're always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

Key Responsibilities

• Ensuring a consistently high-quality experience for end-users.
• Leading a team to oversee quality activities in assigned markets.
• Monitoring and ensuring quality and regulatory compliance of external manufacturers and distributors, including the identification and resolution of non-compliance.
• Oversee new product introduction and supplier qualification, ensuring continued quality compliance of partners.
• Maintain QMS alignment with international standards, health authorities, regulatory guidelines, and company standards.
• Perform batch release in respective markets to ensure compliance with GMP and regulatory requirements.
• Ensure change controls, deviations, CAPA management, recall activities are managed timely and effectively.
• Oversee new product introduction and supplier qualification process.

Requirements

• Bachelors in Science (or a related discipline).
• At least 10 years' experience in the life science industry (e.g. pharmaceuticals, medical devices, and health supplements) in the quality function with strong technical knowledge in GxP.
• Experience leading teams and quality improvement projects.
• Strong business acumen, problem-solving capabilities, communication skills and stakeholder management are important for this position.

To apply, submit your most updated resume showcasing relevant qualifications and experience.

Not the right opportunity?

We're always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

Job Position Summary

• Regulatory Strategy & Line management
• Regional position in MNC
• Medical Devices - Low to High Risk Class

Main Responsibilites

• Manage the submission of documents and handle inquiries from regulatory authorities in assigned regions.
• Develop and execute effective strategies for securing regulatory approvals
• Enhance regulatory processes and implement a system for managing regulatory information.
• Support regulatory aspects during due diligence processes and stay updated on new regulations.
• Analyze regulatory data to gain competitive insights.
• Foster collaboration among departments, providing regulatory expertise and leading regional projects.
• Act as the primary internal regulatory/quality contact, assisting in-country teams and distributors.
• Handle post-marketing quality issues e.g. product complaints/recalls, audits, coordinating FSCA, QMS management and regulatory reporting.

Application Requirements

• Minimum of 5 - 8 years' experience in regional regulatory affairs in medical devices or IVD.
• Bachelor's degree in Pharmacy, Life Sciences, or a related scientific field.
• Thorough familiarity with the global regulatory landscape.
• Strong multitasking and project management skills, coupled with effective communication and collaboration abilities.
• Experience with leading at least 1 other executive will be advantageous.

Interested Applicants

Interested candidates should submit an updated resume that highlights relevant experience and qualifications.

Not the right opportunity?

We're always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

My client a well established Pharma company is looking out for a competent QA Associate, this following are the requirements:

Responsibilities

• Contract/External Manufacturer Quality Oversight: Monitor quality aspects of contract manufacturers, including handling OOS/NCR/Deviation and CAPA, Change Control, and routine stability testing. Ensure compliance with GMP and relevant standards, meeting timelines for actions.
• Releases of products : Oversee batch release to prevent recalls or critical quality issues in the market.
• Change Control: Address individual change controls promptly and efficiently. Manage the change control process, ensuring compliance with GMP and company SOPs. Execute change control tasks within defined timeframes.
• Artwork Review: Conduct artwork reviews to meet requirements.
• Manage deviations, NCR, CAPA: Prevent recalls or critical quality issues related to due diligence.
• Customer Complaints: Collaborate with internal departments and suppliers to oversee the complaints process.
• Document Management:Update SOPs/WIs/FGS as per role responsibilities.
• Internal and External Auditing: Conduct and faciliate resolution audits within specified timeframes, adhering to regulations and SOP and follow up on NCR/CAPA outcomes.

Key Requirements

• Possesses BSc in chemistry, pharmacy, or related field.
• 1 to 3 years of QA experience in pharmaceutical/medical device industry
• Strong familiarity with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
• Experience in supply chain quality, manufacturing quality, or quality management in commercial settings.
• Proficient in deviation management, CAPA, change control, and documentation within pharmaceutical/medical device sectors.
• Auditing experience is desirable.
• High level of attention to details

How to Apply:

Interested applicants may apply by sending in your updated résumé (in MS Word format) to my email or apply directly:

Consultant: Tan Jun Jie

EA personnel reg. no.R1878852

EA License No. 17C8502