Regulatory Affairs Lead

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

• 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.

• 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.