Regulatory Affairs and Quality Manager, APAC
My client, a leading global medical device company, is seeking a Regulatory Affairs and Quality Manager to lead and manage regulatory and quality activities across the APAC region.
Key Responsibilities
- Develop and implement regulatory strategies for APAC markets, ensuring timely submissions, renewals, and compliance with local regulatory requirements (e.g., NMPA, PMDA, TGA).
- Prepare, review, and adapt technical dossiers and global documentation to meet country-specific regulatory standards.
- Ensure alignment of local quality systems with global QMS frameworks (ISO 13485, MDSAP), support audits, and manage Field Safety Corrective Actions (FSCA) and adverse event reporting.
- Oversee in-country testing and certification processes (e.g., China CCC, Taiwan LP0002) and stay updated on evolving standards in medical, EMC, wireless, and safety domains.
- Serve as the primary regulatory liaison between internal cross-functional teams and external regulatory authorities, supporting compliant product launches and lifecycle management.
- Mentor regional RA/QA staff, train distributors, maintain regulatory documentation, and contribute to global regulatory intelligence and strategy development.
Requirements
- Bachelor's degree in Life Sciences, Regulatory Affairs, Engineering, or a related field.
- Minimum of 5 years' experience in regulatory affairs and quality within the medical device industry.
- Proven track record of managing regulatory submissions across multiple APAC countries.
- Strong understanding of medical device regulatory frameworks and quality standards.
- Excellent communication and stakeholder management skills.
If you are interested in this opportunity, please submit your CV for consideration.
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