Regulatory Affairs Associate

Regulatory Affairs (RA) Associate - Medical Devices

Salary: £30,000 - £40,000 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 associate overview

This is a great opportunity for a junior regulatory affairs associate 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 Associate Requirements

• Degree qualified within a relevant STEM field
  
  
• Experience in regulatory affairs is desirable, specifically on medical devices or similar
  
  
• 1 - 3 years of commercial experience (might take a graduate with no experience)
  
  
• 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 associate role, please apply now and we’ll be in touch