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