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
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Support external distributors, authorized reps, and internal teams on regulatory matters
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Compile and maintain MDR-compliant Technical Files and related documentation
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Lead the transition of existing MDD Technical Files to MDR format
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Manage post-market surveillance activities and clinical evaluation maintenance
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Conduct and support complaint trend analysis and ensure accurate reporting
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Monitor changes in global regulatory frameworks and advise management accordingly
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Participate in external audits (e.g. Notified Body) and host internal audits
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Review and approve product, labelling, and process changes for regulatory impact
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Ensure full regulatory compliance in EU, US, and other territories as required
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Liaise with Notified Bodies and coordinate Technical File audits
Candidate Profile
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Degree (2:1 or above) in a scientific or engineering discipline
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Proven experience working with Medical Devices under 93/42/EEC and MDR 2017/745
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Strong understanding of CE Marking, ISO 13485, ISO 14971, and GMP
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Familiar with medical device labelling (ISO 15223) and Essential Requirements Checklists
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Experience liaising with Notified Bodies and supporting audits
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Confident in authoring and maintaining Declarations of Conformity and Technical Files
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Highly organised, hands-on, and commercially astute
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Excellent communication, analytical, and problem-solving skills
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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
