We are seeking an experienced Senior Regulatory Affairs Specialist to join a SME Medical Device company. This is a key role responsible for ensuring our medical devices meet global regulatory requirements and maintain compliance across all markets.You'll play a pivotal role in supporting product registrations, maintaining technical documentation, and working closely with cross-functional teams to ensure regulatory excellence throughout the product lifecycle.
What You'll Be Doing
As a Senior Regulatory Affairs Specialist, you will:
Regulatory Submissions & Compliance
Prepare and submit regulatory documentation and product registration dossiers
Maintain regulatory approvals, licences, and certificates across the portfolio
Coordinate renewals to ensure continuous market access
Technical Documentation & Clinical Evaluation
Develop and maintain Technical Documentation in line with EU MDR (2017/745) and ISO 13485
Support clinical evaluation activities, including plans, reports, and post-market clinical follow-up
Ensure labelling and marketing materials comply with regulatory standards
Contribute regulatory expertise during product design and development
Regulatory Intelligence
Monitor changes in global regulations, standards, and guidance
Assess impact and support implementation across processes and documentation
Maintain regulatory tracking systems and databases
Quality & Post-Market Support
Support audits and inspections (Notified Bodies and Competent Authorities)
Contribute to vigilance and post-market surveillance activities
Assist in maintaining and improving the Quality Management System
Cross-Functional Collaboration
Work closely with Quality, Clinical, Marketing, R&D, and Operations teams
Provide regulatory input for product launches, updates, and discontinuations
Support business-wide understanding of regulatory requirements
What We're Looking For
Essential Experience & Skills
~5+ years in Regulatory Affairs within the medical device industry
Strong knowledge of EU MDR (2017/745), ISO 13485, and global regulatory frameworks
Proven experience with:
Technical documentation and regulatory submissions
Product registrations and regulatory approvals
Clinical evaluation (CERs, CEPs, literature reviews)
Solid understanding of:
Labelling compliance
Product classification and regulatory pathways
Experience with post-market surveillance and vigilance activities
Personal Attributes
Strong communicator able to translate regulatory requirements into practical guidance
Collaborative approach with cross-functional teams
Detail-oriented with excellent organisational skills
Proactive and able to manage multiple priorities
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy
Salary description
£50000.00 - £60000.00 per year