I am collaborating with a leading medical devices manufacturer focusing on oncology therapy. They are expanding within the APAC regions and is inviting an independent and highly driven RA Manager to join their growing team. You will be responsible for all regional regulatory activities (from establishing regulatory strategies, submissions and post-market surveillance activities) and managing distributors and consultants in the various countries.
You will be responsible for:
- Keep abreast on regulations and quality standards changes within the industry. Provide regulatory advice to the business management team and play an active role in regulatory strategies planning.
- Managing submissions for new products, renewals and variations for existing product portfolio across the regions. Report on submissions updates in a timely manner to the business team
- Actively engage with Health/ National Authorities in various countries to strengthen relationships and enhance business branding
- Provide guidance to various local appointed regulatory teams with regard to submissions and to drive submissions approval
You will have:
- A degree in biomedical engineering discipline or equivalent, preferably with a background exposure to oncology therapies
- Minimum 6 years of regulatory experience in medical device, pharmaceutical or healthcare industry across APAC regions is preferred
- Strong communication and interpersonal skills will be advantageous for establishing relationships with both internal and external stakeholders
- Ability to travel is essential.
What is being offered?
- Conducive working culture with exposure to multiple learning opportunities
- Good remuneration package
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).