A world renowned medical devices leader focusing on a niche product portfolio is inviting a highly motivated, independent and meticulous RA Manager to join their growing team. You will be responsible for all regional regulatory activities, providing specific regulatory guidance and ensure that regulatory plans are in-sync with business requirements.
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.
- Engage in regulatory intelligence: establish and implement appropriate regulatory strategies in accordance to various regulatory bodies across regions to achieve successful approvals
- Keep 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.
You will have:
- A degree in scientific discipline or equivalent
- Minimum 6 years of regulatory experience in medical device, pharmaceutical or healthcare industry is preferred
- Strong knowledge in ISO 13485, US FDA, EU MDD/MDR and GDPMDS will be advantageous
- 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).