Regulatory Affairs Associate
Job details
We are looking for a Science or Engineering graduate to join our small Regulatory team based in Yeadon, Leeds as a Regulatory Affairs Associate to ensure that our textile-based, orthopaedic, implantable medical devices can continue to be sold throughout the world. The role:
- Support with generating Technical Files and Device Master Records for newly registered devices.
- Perform Risk Management file reviews and updates for approved devices.
- Perform reviews of documents for other departments in the company.
- Support with day to day regulatory and administrative tasks, i.e., maintenance of Medboard, MHRA site, BSOL, standard reviews etc.,
- It is an industry requirement that you hold a degree in Science or Engineering. Please do not apply if you do not have such a degree, as this is non-negotiable.
- You must be a self-starter, proactive, driven and well organised with good administrative skills.
- Previous experience in a Regulatory or Quality Affairs role within medical devices would be advantageous.
- Experience in supporting distributor approval in a medical device company would also be beneficial.
- Experience in writing and reviewing Technical Files.
- Experience of new product registration in the USA (510k) and EU (CE marking).
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