Regulatory Specialist

Job description

Regulatory Specialist

Pontypridd

£32,000 - £42,000

1 day WFH per week

Are you a Regulatory Affairs professional with experience supporting regulated products across global markets?

We’re looking for a Regulatory Specialist to take ownership of product Technical Files and support regulatory activities across multiple international markets.

What you’ll be doing

• Owning and maintaining product Technical Files across key global registration jurisdictions
• Creating key regulatory documents including Risk Management files, GSPR, Device Descriptions, and labelling
• Organising and supplying documentation for NPD and EU MDR submissions / global registrations
• Supporting the resolution of regulatory-owned quality plans and economic operator agreements
• Identifying applicable standards and external test requirements and proposing options to the Regulatory Manager
• Leading on label creation and templates, resolving operational labelling queries, and contributing to multi-site labelling projects
• Liaising cross-functionally to support Regulatory activities
• Maintaining regulatory logs and supporting internal/external documentation requests
• Monitoring regulatory and industry changes and assessing impact on registrations and processes

✅ What we’re looking for

Essential:

• Degree (or equivalent) in a scientific or engineering discipline
• Minimum 1 year’s experience in Regulatory Affairs
• Strong working knowledge of EU MDR 2017/745, UK MDR 2002, ISO 13485 & ISO 14971
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively in a multi-disciplinary environment
• Proficiency with MS Word, Excel, PowerPoint, and Adobe tools

Desirable:

• Participation in internal auditing programmes
• Experience with MDSAP countries and/or FDA registrations

Salary & Benefits

• £32,000 - £42,000 (dependent on experience)
• 33 days holiday (inclusive of bank holidays) plus holiday trading scheme
• Pension
• Life assurance
• Plus additional benefits

Interested? Apply now or message me to find out more

Extra information

Status

Open

Education Level

Secondary School

Location

Pontypridd

Type of Contract

Part-time jobs

Published at

11-01-2026

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