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