About the role
Regulatory Affairs Specialist needed to compile, review, and edit technical documentation for product registrations and changes in the APAC region. Support channel partners, collaborate with stakeholders, manage adverse events, and stay updated on regulatory requirements. Responsible for maintaining SS620 certification
Life SciencesOnsite
Key Responsibilities
- Compile and review technical documentation for product registrations and changes in APAC.
- Review and edit dossiers to meet APAC countries’ requirements.
- Support APAC channel partners in product registration and compliance.
- Collaborate with stakeholders to gather detailed perspectives and overcome roadblocks.
- Manage Adverse Events and Field Safety Corrective Action reporting.
- Stay updated with regulatory requirements and developments in the APAC region.
Requirements
- B.Sc. in Life Sciences and relevant experience.
- 3-5 years in Regulatory Affairs roles in the IVD or medical devices industry.
- Demonstrated experience in successful product registrations in Asia Pacific countries.
- Knowledge of Asia Pacific countries' IVD standards and regulations.
- Comprehensive knowledge of regulatory requirements in the Asia Pacific region.
- Strong understanding of quality management system and experience in supporting or maintaining QMS systems.