My client is a global leader in the design of complex medical device products and now seek a Manger for RA. They are seeking for someone with an experience in EU regulation.
Responsibilities:
- Assume responsibility as RA Manager to register, maintain and renew product / establishment licenses
- Manage and ensure compliance on product registration and renewal activities
- Provide regulatory advice on business strategy and manage RA projects and services
- Perform yearly Post Market Assessment for products as required by regulations and standards
- Perform 510K pre-market notifications for products registered in relevant countries.
- Handle the specific product registration activities in SEA and new emerging markets
- Ensure regulatory compliance by completing the appropriate filings and documentation pertaining to the company's product registration/approvals
Requirements:
- Degree in life sciences, biotechnology or equivalent with at least 5 years 'experience in RA
- Strong understanding of MDSAP, EU MDR 2017/745, MDD 93/42/EEC, ISO 13485 requirements and ISO 9001 requirements
- Knowledge of related Regulatory and cGMP requirements
- Stronghold in Product Registration, Trademark and CE Mark
- Results-oriented, meticulous and a self-motivated team player
Please send your resume in WORD format by clicking the apply button below or contact Jason Nathan on +65 67011517 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R21101268 (Jason Nathan)
