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Associate Director Regulatory Affairs - Medical Devices and Companion Diagnostics (part time)


Cambridge, Crewe, Dublin

The successful candidate will 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 Email Julia Day, quoting ref 50106