Head of Regulatory Affairs

The ONE Group are proud to be working exclusively with this Cambridgeshire based start-up. They have developed an early stage in-vitro diagnostic device which will be a game-changer in the way viruses are detected and managed. The team are based in Newmarket and there will also be some options for the Head of Regulatory Affairs to work flexibly and partly remote. Benefits are plentiful and, in joining the company at an early stage, you will have the opportunity to be part of something very, very special. Your role will be to lead the regulatory team (currently one other) and take responsibility for creating and maintaining the ISO13485 QMS. You will also manage technical files and communicate with the approved/notified body. As the company grows, your team will, too. And you will have direct input into the hiring process and building your team, who will have success in the UK, EU and US. About You... Relevant degree in a life science / science discipline Minimum 5 years' experience in IVD medical device reg. affairs Knowledge and understanding of UK, EU and US IVD medical device reqs. Experience creating an ISO13485 QMS Experience with IVD regulatory submissions, including CE-marking, IDE, PMA, Pre-submissions. (Experience with IVDR Technical Documentation an advantage). A track record of successful interactions and submissions with regulatory agencies, including Notified Bodies, FDA and vendors/consultants Experience writing and implementing device regulatory SOPs Proven ability in creating and driving an effective regulatory strategy and handling critical issues effectively, with demonstrated creativity in solving regulatory issues Experience building, training and managing a small team For a further conversation, please get in touch

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