Team Manager in opleiding

1 month ago


Oxford Oxfordshire, United Kingdom Lenntech Search Full time

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.
Prepare and submit applications and reports to applicable regulatory agencies.
Respond to reviews and requests for information from regulatory bodies.
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..



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