Salary £ Competitive
Location Cambridge, Crewe or Dublin
Boyds is looking for a part time Associate Director, Regulatory Affairs to join its growing team.
Independently lead projects to develop, review and execute regulatory strategy for clients, and will also take the lead delivering regulatory activities/submissions necessary to support product development and registration.
- Provide expert strategic advice to clients for companion diagnostics and novel devices
- Provide global regulatory diagnostics strategic advice to clients including EU and US
- Prepare and submit regulatory documents including but not limited to, CE documentation, US Q-submissions, US premarket approvals (PMAs) and notifications
- Review of documentation to support gene therapy submissions, including IMPD/CTA/IND, scientific advice briefing documents, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions and other regulatory filings to support regulatory compliance
- Lead regulatory agency interaction and negotiations
- At least a Life Sciences degree.
- Significant experience in medical device regulatory affairs with some experience in Companion Diagnostics and ATMPs is strongly preferred
- Extensive experience leading the development of Regulatory Strategy.
- Strong experience with EU and/or US submissions and regulations.
- Experience with IVD regulatory submissions including CE-marking, IDE, PMA, Pre-submissions. Experience with IVDR Technical Documentation an advantage.
- Self-starter with the ability to independently find creative solutions for complex problems. A strong customer focus with a flexible approach to work and a willingness to share ideas and experiences
Apply: Email Julia Day firstname.lastname@example.org, quoting ref 50106.