Regulatory Affairs Specialist

A leading medical device manufacturer based in South Wales is seeking a Regulatory Specialist to join its Regulatory Affairs team.

This is an excellent opportunity to be part of a growing, multinational organisation with a diverse portfolio of medical devices marketed globally.

As a Regulatory Specialist, you will play a key role in supporting global product registrations and maintaining technical documentation across multiple jurisdictions. Working closely with cross-functional teams including R&D, Quality, Operations, and Supply Chain, you will help ensure products meet applicable regulatory and standards requirements throughout their lifecycle.

Key Responsibilities:

• Ownership and maintenance of technical files for medical devices across key global markets
• Preparation and generation of regulatory documentation, including GSPR, risk management files, device descriptions, and labelling content
• Supporting EU MDR and UKCA submissions, as well as global registration activities
• Coordinating documentation to support new product development (NPD) and change activities
• Identifying applicable standards and testing requirements and proposing compliance strategies

To be successful in this role, you will demonstrate:

• A degree (or equivalent) in a scientific or engineering discipline
• 3-5 years of experience in Regulatory Affairs within the medical device industry
• Working knowledge of EU MDR (2017/745) and UK MDR 2002 (as amended)
• Familiarity with ISO 13485 and ISO 14971
• Strong written and verbal communication skills
• Ability to work independently while contributing effectively within a cross-functional team
• Proficiency with documentation tools such as Microsoft Word, Excel, PowerPoint, and Adobe

Desirable Experience:

• Participation in internal or external audits
• Exposure to FDA submissions, MDSAP countries, or global regulatory systems

This role offers the chance to develop your regulatory career within a supportive and collaborative RAQA team, contributing directly to the safe and compliant delivery of medical devices used by patients worldwide.

Regulatory Specialist | Regulatory Affairs | Medical Devices | EU MDR | UKCA | ISO 13485 | ISO 14971 | Technical Files | Labelling