Regulatory Associate

Full Job Description

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).

Salary & Benefits:

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.

Please note we cannot accept applications from candidates who are not based in the UK or who require visa sponsorship.
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