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Regulatory Affairs Specialist (Medical Devices)

Salary: £25,000 - £35,000 per annum

Benefits include: Monthly paid bonuses, 25 days holiday (plus bank holidays), pension scheme, training and progression

Location: Aston Clinton (Aylesbury), Buckinghamshire

Regulatory Affairs Specialist Overview

This is a great opportunity for a regulatory affairs specialist / junior to join a growing medical engineering business based in Buckinghamshire. The company is a small part of a larger 300 employee business. The group designs and manufactures leading-edge electro-surgical tools, alongside the creative development of future surgical systems.

The business are looking for either a graduate in a STEM field looking to move into regulatory affairs and quality assurance, or someone with 1-3 years of commercial experience. The regulatory affairs specialist will need to come from an engineering background, ideally medical devices, as opposed to a drug development / pharma background.

You will join a small RA/QA team, comprised of two other RA/QA specialists. You will aid in the compliance certifications of new products, file technical documentation for MDR/FDA regs and be involved in biocompatibility reports, clinical evaluations, risk assessments and post-market surveillance (and more!).

Regulatory Affairs Specialist Requirements

* Degree qualified within a relevant STEM field

* Experience in regulatory affairs is desirable, specifically on medical devices or similar

* Knowledge of MDR and FPA compliance

* A good team-player with excellent communication skills

* A desire to join a high-performing team within a growing organisation

If you are interested in discussing this regulatory affairs specialist position, please apply now and well be in touch

Benefits: Bonus paid monthly, pension etc