Regulatory Affairs Specialist

Walker Cole International is supporting a leading medical device company in Hertfordshire in the search for a Regulatory Affairs Specialist to ensure compliance with global regulatory requirements. This position will play a key role in supporting product registrations, maintaining technical documentation, and liaising with regulatory authorities.

As the Regulatory Affairs Specialist, you will be responsible for:

• Preparing, reviewing, and submitting regulatory documentation to support product registrations in the UK, EU, and global markets.
• Maintaining compliance with MDR, IVDR, and ISO 13485 requirements.
• Supporting the creation, maintenance, and review of Technical Files and Design Dossiers.
• Acting as a key point of contact for regulatory authorities and notified bodies.
• Collaborating cross-functionally with R&D, Quality, and Manufacturing teams to ensure regulatory requirements are met throughout the product lifecycle.
• Monitoring changes in regulatory legislation and standards, ensuring internal policies remain up to date.

The ideal candidate will have:

• Proven Regulatory Affairs experience within the Medical Device industry.
• Knowledge of EU MDR, IVDR, ISO 13485, and international regulatory frameworks.
• Experience preparing and maintaining Technical Files and product registrations.
• A BSc Degree in a life science, engineering, or related discipline.
• Strong communication and cross-functional collaboration skills.

Desirable experience:

• Experience interacting with notified bodies and regulatory authorities.
• Familiarity with FDA 21 CFR Part 820 requirements.
• Previous involvement in CE marking or global submissions.

Regulatory Affairs | RA Specialist | Medical Devices | MDR | IVDR | ISO 13485 | Technical File | CE Marking | FDA | 21 CFR 820 | Notified Body | Product Registration | Regulatory Compliance | Design Dossier | Regulatory Submissions | EU MDR | Global Submissions | Lifecycle Management