Regulatory Affairs Specialist
22 hours ago
Eton
Job Title: Regulatory Associate – Medical Devices Location: West London/ Berkshire (Hybrid or On-site, depending on candidate location) Employment Type: Full-Time 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. Key Responsibilities • 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 Candidate Profile • 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 Why Apply? 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.
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