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Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full timeKey ResponsibilitiesThe successful Head of Regulatory Affairs will be responsible for 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. You will play an...
Senior Regulatory Affairs Director
1 month ago
We are a world-leading biotech company at the forefront of liquid biopsy technology, developing a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner.
Role OverviewWe seek an experienced Head of Regulatory Affairs to join our team in Guildford as Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, ensuring the organisation meets all relevant regulatory standards across global markets.
Responsibilities- Provide strategic direction and operational oversight to the regulatory and quality teams, managing compliance with international medical device directives and regulations.
- Define regulatory strategies, guide clinical and analytical validation studies, and liaise with regulatory authorities to support new product development.
- 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.
We offer the opportunity to influence the global commercial rollout of a revolutionary cancer diagnostic technology, making a significant impact in cancer diagnostics. The salary range for this role is £70,000 - £90,000 per annum, depending on experience.
