Barrington James are excited to post a fantastic opportunity for one of our close clients. We're seeking an experienced Regulatory Affairs Director to lead global regulatory strategy for a small Medical Device manufacturer. They are backed by some serious investors the industry and are looking for future support within their regulatory team. This opportunity is perfect for someone who is ambitious, independent and wants to play a key role in working on the most innovative projects.
Key Responsibilities
- Develop, plan and implement global regulatory strategies
- Lead submissions for FDA, EU MDR, MHRA, and other global bodies
- Manage agency interactions and regulatory audits
- Ensure compliance with QSR, ISO 13485, EU MDR
- Mentor and lead regulatory staff efficiently, to meet targets and goals
Requirements
- 10+ years in regulatory affairs for medical devices
- Proven track record with U.S./EU submissions (510(k), PMA, MDR)
- Strong leadership, project management, and communication skills
- RAC certification or Master’s preferred
The opportunity has understandably been incredibly popular. We encourage all interested candidates to apply immediately as it is likely that recruitment will close prematurely.
By clicking "apply" you will be sending your CV to Tyler Bosier at Barrington James. Tyler is a specialist Regulatory Affairs recruiter and will discuss the opportunity in detail with you, facilitate your application and will manage the process acting as a link between the company and yourself.
Please call +44 12 93 77 66 44 if you have any questions, alternatively you can reach Tyler on