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Medical Device Regulatory Affairs Associate

3 months ago

Yeadon England, United Kingdom Xiros Full time
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.

If your skills, experience, and qualifications match those in this job overview, do not delay your application.
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.,
Essential Requirements:
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.
Desirable Requirements:
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).

Starting salary £33,250 p.a. with opportunity for progression. Excellent range of core and flexible benefits including non-contributory S.I.P.P; cash plan; opportunity for private medical insurance, gym membership, Metro-card; enhanced holiday allowance; subsidised lunches; free drinks and fruit; wellness programme; free and subsidised sports and social events; company parties; flexi-time; opportunity to work on site three days per week and remotely two days per week; ongoing training and development.