🌟Regulatory Specialist
đź“Ť Pontypridd
đź’· ÂŁ32,000 - ÂŁ42,000
🏡 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
đź’°Salary & Benefits
* ÂŁ32,000 - ÂŁ42,000 (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 đź’¬