Regulatory Specialist

Regulatory Specialist – Medical Devices

Location:

South Wales (Hybrid/Flexible working considered) Sector:
Medical Devices

We are seeking a Regulatory Specialist to join a growing Regulatory Affairs team within a medical device organisation operating across global markets. This role offers hands‑on involvement across EU MDR, UK MDR, and international registrations, supporting both new product development (NPD) and lifecycle activities.

This is an excellent opportunity for a regulatory professional looking to build depth in MDR/UKCA, work cross‑functionally, and gain ownership of technical documentation and labelling activities.

• Own and maintain product Technical Files and associated regulatory documentation across key global jurisdictions
• Generate and maintain key regulatory documents including Risk Management files, GSPR, Device Descriptions, and labelling
• Organise and supply documentation to support EU MDR submissions, registrations, and NPD activities
• Support resolution of regulatory‑owned quality plans and contribute to economic operator agreements
• Identify applicable standards and external testing requirements, proposing regulatory strategies and options
• Lead the creation of labels and label templates, resolving operational labelling queries and supporting multi‑site labelling projects
• Liaise with R&D, Quality, Operations, and other departments to support regulatory activities
• Create regulatory statements, rationales, and responses for internal and external stakeholders
• Maintain regulatory logs, databases, and documentation records
• Monitor regulatory and standards changes and assess potential impacts on registrations and processes

• Degree (or equivalent) in a scientific or engineering discipline
• Minimum 1 year of experience in Regulatory Affairs within the medical device industry
• Working knowledge of:
• EU MDR (2017/745) and UK MDR 2002 (as amended)
• ISO 13485 (Quality Management Systems)
• ISO 14971 (Risk Management)
• Ability to work independently and collaboratively within cross‑functional teams
• Strong written and verbal communication skills
• Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe tools

• Participation in internal audit programmes
• Exposure to MDSAP countries and/or FDA regulatory systems
• Experience supporting international registrations beyond the EU/UK

• Hands‑on exposure to EU MDR submissions and global regulatory activities
• Opportunity to grow within a supportive and experienced Regulatory team
• Involvement across the full product lifecycle, from development to post‑market
• A role that offers career progression, learning, and real regulatory ownership

Apply now!