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Regulatory affairs officer overview
This is a great opportunity for a junior regulatory affairs (RA) officer, which also involves elements of QA, quality assurance, 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 is 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 should 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 assist in the compliance certifications of new products, file technical documentation for MDR/FDA regulations, and be involved in biocompatibility reports, clinical evaluations, risk assessments, and post-market surveillance, among other responsibilities.
Regulatory Affairs Officer Requirements
* Qualified within a relevant STEM field
* Experience in regulatory affairs is desirable, specifically on medical devices or similar
* 0 - 3 years of commercial experience
* Knowledge of MDR and FDA compliance
* A good team-player with excellent communication skills
* A desire to join a high-performing team within a growing organization
Seniority level
* Associate
Employment type
* Full-time
Job function
* Science, Engineering, and Manufacturing
Industries
* Medical Equipment Manufacturing, Manufacturing, and Pharmaceutical Manufacturing
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Locations: Dunstable, Oxford, Maidenhead, Uxbridge, England, United Kingdom (various postings within the last 3 weeks).
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