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Senior Regulatory Affairs Director for Liquid Biopsy Technology
1 month ago
We are a world-leading biotech company at the forefront of liquid biopsy technology, capturing rare circulating tumour cells from blood in a minimally invasive manner. Our patent-protected platform pushes the boundaries of cancer diagnostics and personalised medicine.
Job Title: Senior Regulatory Affairs Director for Liquid Biopsy TechnologyLocation: GuildfordEstimated Salary: £80,000 - £110,000 per annum
About the RoleWe seek an experienced Senior Regulatory Affairs Director to join our team in Guildford. As Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, you will ensure our organisation meets all relevant regulatory standards across global markets. You will provide strategic direction and operational oversight to the regulatory and quality teams, managing compliance with international medical device directives and regulations, including ISO13485 and ISO15189.
You will play an essential role in new product development by defining regulatory strategies, guiding clinical and analytical validation studies, and liaising with regulatory authorities. This position offers the opportunity to influence the global commercial rollout of a revolutionary cancer diagnostic technology.
Your Key Responsibilities- Experience in IVD medical device product development, adhering to standards such as ISO14971.
- In-depth knowledge of global medical device directives, including FDA regulations, MEDDEV guidelines, and ISO standards.
The ideal candidate will possess:
