Regulatory Affairs Specialist

SRG

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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