Biotech Regulatory Compliance Lead

15 hours ago


Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time
Key Responsibilities

The 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 essential role in new product development (NPD) and provide strategic direction to the regulatory and quality teams.

The ideal candidate will have 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 is required.

Benefits: The successful candidate will enjoy a competitive salary, excellent benefits package, and the opportunity to work on cutting-edge projects in the biotech industry.

Estimated Salary: £90,000 - £110,000 per annum.

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