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    Regulatory Affairs Lead

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      Regulatory Affairs Lead

      Location: Oxford

      Salary: £70-80,000

      Contract Type: Permanent

      LennTech Search are working with an innovative software medical device company whom have a need for an experienced Regulatory Affairs Manager.

      Main Duties

      • Lead company regulatory submissions to the FDA.
      • Preparation of full 510(k) Q-Submissions.
      • Prepare and submit applications and reports to applicable regulatory agencies.
      • Respond to reviews and requests for information from regulatory bodies.
      • Ensure post-market surveillance is completed in line with applicable regulations.
      • Lead vigilance and regulatory authority reporting activities when required.

      Education and Experience

      • Knowledge and/or experience in development of software (including AI) as a medical device.
      • Knowledge and/or experience in medical device regulatory requirements in the US, Canada and China are preferable..
      • Experience in a start-up or a fast-growing company.
      John Lennon

      Posted by

      John Lennon

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