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Job Opportunity: Junior Regulatory Affairs (RA) Officer
This is a great opportunity for a junior regulatory affairs (RA) officer, which also involves elements of QA, to join a growing medical engineering business based in Buckinghamshire. The company is a small part of a larger 300-employee group that designs and manufactures leading-edge electro-surgical tools and develops future surgical systems.
The business is looking for either a graduate in a STEM field aiming to move into regulatory affairs and quality assurance, or someone with 1-3 years of relevant commercial experience. The ideal candidate will have an engineering background, preferably in medical devices, rather than drug development or pharma.
You will join a small RA/QA team consisting of two other specialists. Your responsibilities will include aiding in the compliance certification of new products, filing technical documentation for MDR/FDA regulations, and participating in biocompatibility reports, clinical evaluations, risk assessments, and post-market surveillance activities.
Regulatory Affairs Officer Requirements
1. Degree qualified within a relevant STEM field
2. Experience in regulatory affairs is desirable, specifically in medical devices or similar fields
3. 0 - 3 years of relevant commercial experience
4. Knowledge of MDR and FDA compliance
5. A good team player with excellent communication skills
6. Desire to join a high-performing team within a growing organization
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