Regulatory Affairs Specialist

Are you a Regulatory Affairs Specialist professional with experience supporting regulated products across global markets? Were looking for a Regulatory Affairs Specialist to take ownership of product Technical Files and support regulatory activities across multiple international markets. Salary & Benefits £32,000 - £42,000 (dependent on experience) 1 day WFH per week 33 days holiday (inclusive of bank holidays) plus holiday trading scheme Pension Life assurance Plus additional benefits What youll 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 were looking for Essential:
Degree (or equivalent) in a scientific or engineering discipline Minimum 1 years experience in Regulatory Affairs Specialist within Medical Devices 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