I am collaborating with a medical devices manufacturer who is the market leader in their niche field of offerings. This is a new position and the team is inviting an independent and highly-driven RA Manager to join their growing team. You will be responsible for regulatory activities across APAC regions, ensuring timely regulatory approvals are obtained for various markets and to manage post-market surveillance activities. You will be heavily interfacing with both internal and external stakeholders to develop regulatory strategies and provide regulatory guidance to cross-functional teams.
You will be responsible for:
- Managing submissions for new products, renewals and variations for existing product portfolio across the regions. Exercising due diligence in reviewing technical documents to fulfill different regulatory bodies' requirements.
- Establishing and implementing the regulatory processes and SOPs
- Post-market surveillance activities, supporting on product complaints, adverse events and recalls.
- Keeping abreast on regulations and quality standards updates in the industry. Provide advice to management team should any updates/changes impact products in the region and ensure implementation of resulting actions
- Reviewing and ensuring promotional marketing materials and labels are in line with company's requirements and various regulatory requirements.
- Liaising with both internal and external stakeholders to ensure regulatory compliance and provide regulatory advice whenever necessary
You will have:
- A degree in scientific discipline or equivalent. Certification in regulatory affairs will be advantageous.
- Minimum 6 years of regulatory experience in medical device industry is preferred
- Strong knowledge in ISO 13485, US FDA, EU MDD/MDR and GDPMDS and various regulatory standards across the APAC. Prior knowledge in FDA 510K will be advantageous.
- Good communications skills in English (both oral and written) to facilitate accurate information flow between departments
- The ability to travel (~30%)
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).