S$6000 - S$8000 per month
3 months ago
Want to be part of a new organization which is aggressively building their new directive in medical space? A rare opportunity has come up with a Fortune 500 conglomerate and they are building their RA team across APAC regions. You will be assuming the role of a Senior Regulatory Affairs Specialist, reporting into the APAC RA Director.
You will be responsible for:
- Submissions and following up of product registrations to various regulatory bodies in a timely manner. Exercise due diligence in reviewing technical documents to fulfill different regulatory bodies' requirements.
- Post-market surveillance activities, supporting on product complaints, adverse events and recalls.
- Reviews marketing labels for accuracy and compliance with international standards. Ensure promotional materials are approved by health authorities
- Liaise with both internal and external stakeholders to ensure regulatory compliance and provide regulatory advice whenever necessary
What will make you the successful individual:
- Bachelor's degree or equivalent in Biotechnology/ Bio-engineering or related scientific discipline
- Minimum 5 years of regulatory experience in medical devices industry is preferred
- Good communications skills in English (both oral and written) to facilitate accurate information flow between departments.
Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).