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Snr. Director Quality & Regulatory Affairs
- Posted: 07/09/2024
- Salary: Competitive
- Location: Milford, Massachusetts, United States
- Job Type: Permanent/Fixed Term
Opportunity to join a global diagnostics company as they look to bring new products to the market. Leading an international team of 15, you'll be responsible for predominantly the regulatory strategy of their IVD products.
Responsibilities
Responsibilities
- Oversee the process of preparing product submissions and registrations to domestic and international regulatory bodies, managing the process from inception to approval and maintenance.
- Manage and conduct Regulatory Affairs activities including those related to New Product Development, Change Management, Post Market, potential Adverse events.
- Advanced degree in a Life Science field, MBA or equivalent
- 15+ years of extensive regulatory affairs experience within medical devices, IVD experience essential.
- Extensive and proven understanding of FDA and global regulations, including China, Europe's IVDR, APAC, and Brazil
Callum Sparkes
Director