Regulatory Affairs Specialist

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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