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.
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