We are currently working with a highly innovative and fast-evolving medical device organisation looking to expand their Regulatory Affairs team with a new Senior Regulatory Affairs Specialist.

This is a great opportunity for someone with strong regulatory expertise, particularly in biological evaluation, biocompatibility (ISO 10993) and EU MDR/FDA pathways. We are looking for someone who is passionate about ensuring safe, compliant products reach patients faster. You will work cross-functionally with teams in Quality, R&D, Clinical and Regulatory to support both internal pipeline projects and client-based programmes.

What You’ll Be Doing:

• Leading regulatory strategy and submissions for new and existing medical devices and developing biological evaluation plans and risk assessments in line with ISO 10993
• Preparing documentation to support pre-clinical and clinical regulatory filings
• Managing relationships with regulatory agencies and responding to information requests and acting as a subject matter expert (SME) on biological safety across product portfolios
• Working closely with testing labs, toxicologists and consultants to support evaluation protocols
• Supporting risk management files in line with ISO 14971 and maintaining regulatory compliance
• Reviewing internal documentation and labelling to ensure global regulatory alignment

What We’re Looking For:

• Strong regulatory affairs background in the medical devices industry
• In-depth experience with biocompatibility, biological evaluation, ISO 10993, and global regulatory pathways
• Proven track record supporting CE marking (MDD/MDR) and/or US FDA submissions
• Confident working across multiple simultaneous projects in a fast-paced, highly regulated environment
• A collaborative, analytical thinker with excellent documentation and communication skills
• Experience working with external testing labs and regulatory consultants
• Familiarity with Veeva, document control systems, or similar tools would be a plus

Whether you’re ready for your next challenge or seeking to work on complex and strategic submissions, this is a fantastic opportunity to join a company pushing boundaries in the device space.