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Director, Global Regulatory Affairs, Oncology Precision Medicine
161360
Posted:
05/03/2025
- Competitive
- ., France
- Permanent
Are you an experienced Regulatory Affairs professional with a passion for medical devices and in vitro diagnostics (IVDs)? We’re looking for a Regulatory Affairs Strategist to join our leading pharma client! In this pivotal role, you’ll provide strategic advice to support the development and registration of medical devices, with a special focus on IVDs and companion diagnostic products.
As a leader, you will be a key player in shaping regulatory strategy, working with R&D teams and cross-functional stakeholders to drive optimal outcomes in product development.
This position can be located in the greater London or greater Paris area.
Key Responsibilities:
Required Experience & Qualifications:
As a leader, you will be a key player in shaping regulatory strategy, working with R&D teams and cross-functional stakeholders to drive optimal outcomes in product development.
This position can be located in the greater London or greater Paris area.
Key Responsibilities:
- Provide strategic regulatory guidance on development and registration strategies across the company’s product portfolio, focusing on medical devices and IVDs.
- Support the development of biomarkers, diagnostic tests, and digital health tools, offering regulatory expertise to drive product success.
Required Experience & Qualifications:
- Industry Experience: Minimum of 10 years in regulatory affairs, specifically in the development and registration of medical devices and IVDs, with strong expertise in Europe and the US.
- Regulatory Knowledge: In-depth understanding of international regulatory requirements (FDA/CDRH, EMA, ISO 13485, IVDR, etc.).
- Proven track record of successfully navigating medical device and IVD registrations.
Kaitlyn Sumner
Account Manager