RA Associate

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, authorized 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