Regulatory Specialist in Eton

Job description

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.

Extra information

Status

Open

Education Level

Secondary School

Location

Eton

Type of Contract

Part-time jobs

Published at

11-08-2025

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English