Regulatory Affairs Specialist

About This Role

This role involves championing global regulatory compliance and driving strategy to ensure seamless market access for cutting-edge medical technology products across multiple regions. The Regulatory Affairs Specialist will join a growing RAQA team on a permanent basis and will suit an experienced regulatory professional looking for a long-term career move.

Responsibilities

• Lead and manage critical regulatory submissions, with a primary focus on EU MDR technical files and FDA 510(k)
• Produce and maintain essential clinical (CEP, CER) and post-market surveillance (PMSP, PSUR) documentation
• Guide cross-functional Product and Engineering teams to embed regulatory requirements directly into the product development lifecycle
• Manage vigilance activities and drive new regional product registrations

Requirements

• A solid regulatory affairs background within the medical device sector
• Proven, hands-on success with EU MDR or FDA 510(k) submissions
• Deep working knowledge of ISO 13485:2016, MDSAP, ISO 14971, IEC 62304, and ISO 62366-1
• A relevant degree in Life Sciences, Biomedical Engineering, Computer Science, or Regulatory Affairs
• Direct experience with Software as a Medical Device (SaMD) and an understanding of medical imaging modalities

About the Company

This innovative medical technology business focuses on developing cutting-edge products.