Regional Quality Assurance & Regulatory Affairs Manager (APAC)

MICHAEL PAGE INTERNATIONAL PTE LTD; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A global leader in wound care is seeking a Regulatory Affairs and Quality Assurance professional in Singapore. The ideal candidate should have extensive experience in regulatory compliance within the medical device industry and hold a Bachelor's degree along with ISO 13485 certification. This position offers a supportive company culture with opportunities for professional development.

Benefits

Engaging company culture

Professional development opportunities

Qualifications

• 5-8+ years of experience in the medical device industry.
• ISO 13485 Lead Auditor certification preferred.
• Strong understanding of regulatory requirements in APAC.

Responsibilities

• Collaborate with Global HQ for product registrations.
• Ensure regulatory compliance in Singapore and Asia.
• Maintain effective Quality System aligned with ISO standards.

Skills

Regulatory compliance

Quality management

Stakeholder management

Project management

Communication

Education

Bachelor's degree

Tools

ISO 13485

GMP

Job description

About Our Client

My client is a well-established global leader in wound care. They design and manufacture advanced medical dressings, compression systems, skincare products, and related medical devices - working closely with healthcare professionals and investing heavily in R&D and clinical evidence.

Job Description

Regulatory Affairs

• Collaborate with Global HQ to secure registrations for new products across multiple countries.
• Ensure regulatory compliance of products in Singapore and other Asian markets.
• Monitor Asia regulatory guidelines, advise HQ, and provide recommendations (e.g., stability studies, registration file requirements).
• Keep QA/RA Managers in APAC updated on HQ developments such as new product launches and regulatory variations.
• Build and lead a QARA community across the region, fostering strong relationships with both country teams and global functions.
• Analyze regulatory requirements when entering new markets.
• Coordinate regulatory filings and renewals in partnership with distributors and external partners.
• Ensure submissions and product claims are fully supported by technical documentation.
• Support the development, review, and implementation of regional regulatory and quality processes.
• Partner with Supply Chain, Marketing, Finance, Sales, and other departments to identify risks and propose mitigation plans.
• Align and communicate regulatory strategy across internal and external stakeholders.
• Review labelling and marketing materials to ensure compliance with regulatory approvals.

Quality Assurance

• Implement and maintain an effective Quality System aligned with ISO 13485, GMP, MDD 93/42 EEC, MDR 2017/745, and other relevant standards.
• Act as Management Representative for GDPMDS and Qualified Person for the Singapore market.
• Maintain and improve the Quality Management System (e.g., drafting/revising SOPs to meet evolving business needs).
• Ensure Quality Systems are correctly implemented and maintained across regional offices and affiliates, driving continuous compliance improvements.
• Lead self-assessments, Notified Body audits, and Health Authority inspections.
• Track and report Quality KPIs to HQ in a timely manner.
• Manage customer complaints, FSCA, recalls, and withdrawals.
• Lead change controls, deviations, and CAPA management.
• Oversee quality and regulatory aspects of non-group product development, sourcing, and supply in Asia: Conduct supplier, distributor, and subcontractor audits.
• Audit manufacturing and sterilization facilities when required.
• Monitor and close CAPAs.
• Establish and maintain quality/regulatory agreements and technical specifications.

The Successful Applicant

• Bachelor's degree holder
• 5-8+ years of Quality and Regulatory experience in the medical device industry.
• ISO 13485 Lead Auditor certification and GMP knowledge (sterile and non-sterile medical devices) preferred.
• Strong understanding of GDPMDS, ISO 13485, TGA, NMPA, PMDA, ASEAN MDD, MDSAP, EU MDD 93/42 EEC, and MDR 2017/745 requirements.
• Proven experience working with stakeholders across APAC markets.
• Skilled at managing multiple projects and priorities.
• Experience managing teams directly or indirectly within a matrix environment.
• High integrity, proactive, and collaborative with strong relationship-building skills.
• Strong business partnering, communication, and stakeholder management capabilities.
• Solid knowledge of regulatory frameworks and direct experience engaging with local regulatory authorities.

What's on Offer

• Opportunities to work within a leading organisation in the healthcare industry.
• Engaging and supportive company culture.
• Professional development and career progression opportunities.

If you are passionate about quality assurance and regulatory affairs and are looking to make an impact in Singapore's healthcare retail sector, we encourage you to apply for this exciting opportunity

Contact

Hazel Choi (Lic No: R24122391 /EA no: 18S9099)

Quote job ref

JN-092025-6844940

Phone number

[phone]