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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.

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