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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? Were 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? Youll 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.55b20050-bc17-4e5d-bfce-3c406318dffc