Regulatory Affairs Specialist
Job Type
Permanent
Location
London
Salary
£50,000 - £60,000 per annum
Job Ref
BBBH185303_1782132343
Date Added
June 22nd, 2026
Consultant
Laith Mustafa
About the Role
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.
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