Regulatory Affairs Specialist
Location: Singapore
About Us
Join a leading global medical device company dedicated to advancing healthcare and improving patient outcomes worldwide. With a strong commitment to quality, innovation, and patient safety, they are expanding their reach across the dynamic Asia-Pacific markets.
Key Responsibilities
- Coordinate product registration and market access approval in designated APAC countries.
- Provide expert advice on interpreting regulatory guidance and standards to internal and external teams.
- Liaise with local authorities for regulatory problem-solving and to obtain updated information on developing regulations.
- Lead comprehensive post-market surveillance activities, including complaint reporting, analysis, FSCA, and recall coordination.
Qualifications
- At least 2 years of experience in regulatory affairs within the medical device industry.
- Strong knowledge of medical device regulations and the APAC regulatory landscape (including post-market surveillance).
- Proactive, detail-oriented, with excellent communication and problem-solving skills.
- Ability to collaborate effectively across functions and manage multiple tasks.
Interested applicants, please click APPLY NOW.
Please note, only shortlisted candidates will be contacted.
