Regulatory Affairs Specialist

Location: West London/ Berkshire (Hybrid or On-site, depending on candidate location)

Employment Type: Full Time

Contact: |

Are you looking to advance your career in Regulatory Affairs within a fast-paced and impactful medical device environment? We’re hiring a Regulatory Associate to join a highly collaborative RA/QA team and play a central role in global product compliance and regulatory strategy execution.

This is an exciting opportunity for someone with strong knowledge of the Medical Device Directive (93/42/EEC), EU MDR (2017/745), and ISO 13485, who thrives on autonomy, ownership, and making a real contribution to patient safety and product success.

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• Prepare and maintain global regulatory submissions and renewal
  
• Support external distributors, authorised reps, and internal teams on regulatory matters
  
• Compile and maintain MDR-compliant Technical Files and related documentation
  
• Lead the transition of existing MDD Technical Files to MDR format
  
• Manage post-market surveillance activities and clinical evaluation maintenance
  
• Conduct and support complaint trend analysis and ensure accurate reporting
  
• Monitor changes in global regulatory frameworks and advise management accordingly
  
• Participate in external audits (e.g. Notified Body) and host internal audits
  
• Review and approve product, labelling, and process changes for regulatory impact
  
• Ensure full regulatory compliance in EU, US, and other territories as required
  
• Liaise with Notified Bodies and coordinate Technical File audits
  

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• Degree (2:1 or above) in a scientific or engineering discipline
  
• Proven experience working with Medical Devices under 93/42/EEC and MDR 2017/745
  
• Strong understanding of CE Marking, ISO 13485, ISO 14971, and GMP
  
• Familiar with medical device labelling (ISO 15223) and Essential Requirements Checklists
  
• Experience liaising with Notified Bodies and supporting audits
  
• Confident in authoring and maintaining Declarations of Conformity and Technical Files
  
• Highly organised, hands‑on, and commercially astute
  
• Excellent communication, analytical, and problem‑solving skills
  
• Ability to work independently and collaboratively in cross‑functional teams
  

You’ll be joining a passionate team that values quality, innovation, and continuous improvement. This role offers a unique opportunity to shape compliance processes and directly impact global patient access to life‑enhancing medical devices.

To apply, please submit your CV and a short cover note outlining your suitability. For a confidential discussion about the role, feel free to get in touch directly.