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