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.
Key Responsibilities
* 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
Essential Requirements
* 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
Desirable Experience
* Participation in internal audit programmes
* Exposure to MDSAP countries and/or FDA regulatory systems
* Experience supporting international registrations beyond the EU/UK
Why Join?
* 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!