Regulatory Affairs Manager

Vedra Med Tech
West Bromwich
12 Apr 2018
27 Apr 2018
Contract Type
Full Time
Vedra are excited to be representing a rapidly growing medical devices company in their search for a Regulatory Affairs Manager to be based out of the offices in the surrounding area of Birmingham. My client have roughly 100 employees based out of the UK site and are due to expand over the course of the next 2 years which will create opportunities for the Regulatory Affairs Manager to accelerate their career as they grow the regulatory team. This is an innovative, friendly environment working with cutting edge technology that is saving lives every day.

Leading a regulatory team of 3, the Regulatory Affairs Manager will be responsible for ensuring the CE status and Technical files are updated and maintained. A large aspect of the role will be leading a FDA 510K application process ensuring it is completed within the set timeframes. In addition the role will be responsible for leading and documenting Risk Management activities in accordance with ISO14971.

To be considered for this role it is essential that you have worked in a medical devices environment and are familiar with ISO13485 and FDA 231 CFR pt 820. You will have knowledge of regulatory requirements for CE marking and will have experience leading a 510K application. Ideally you will have experience with people management or will have reached a stage where you are ready to take the step into leading and growing a team.

We are looking to move quite quickly in the selection process for this position so please do not hesitate to apply. Further details on this role can be provided upon application.
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