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.