Clinical Regulatory Specialist

Recruitment Consultant I Regulatory Affairs and Quality Assurance Specialist I Permanent ( UK & Europe )

I am seeking a Clinical Regulatory Specialist to join an innovative medical technology company at the forefront of surgical AI and digital health. The role is critical to ensuring clinical evidence, regulatory submissions, and compliance activities meet UK and international medical device regulations. You will work across clinical, regulatory, and R&D teams to enable safe and timely access to cutting‑edge healthcare solutions.

• Develop and execute regulatory strategies for clinical evidence and submissions in the UK (MHRA/UKCA) and support international regulatory planning.
• Prepare and author regulatory dossiers, clinical evaluation plans, and submission documents.
• Interpret and advise on UK and international medical device regulations, including UKCA, UK MDR, EU MDR, ISO 14155, ICH‑GCP, and SaMD guidance.
• Collaborate with Clinical, QA/RA, and R&D teams to define clinical evidence requirements.
• Evaluate clinical literature, trial data, post‑market data, and real‑world evidence to support regulatory submissions.
• Maintain and update regulatory files, design dossiers, technical documentation, and clinical evaluation reports.
• Support post‑market clinical follow‑up (PMCF) planning and execution.
• Provide regulatory guidance and training to internal teams on clinical regulatory requirements.
• Serve as a regulatory point of contact with regulatory authorities as required.

• Degree in Life Sciences, Biomedical Engineering, Medicine, Pharmacy, or related field.
• Regulatory qualifications (e.g., RAC, MSc in Regulatory Affairs) are advantageous.

• 3–7+ years in regulatory affairs or clinical regulatory roles within medical devices, SaMD, digital health, or similar sectors.
• Experience with clinical evaluation planning, clinical literature review, PMCF, and regulatory submissions.
• Exposure to MHRA/UKCA processes and EU MDR/CE marking is desirable.

• Strong understanding of UK and international regulatory frameworks for medical devices and SaMD.
• Knowledge of clinical regulations including UKCA, ISO 14155, ICH‑GCP, and post‑market surveillance.
• Ability to interpret complex clinical and regulatory guidance for strategic application.

• Excellent technical writing and documentation skills.
• Strong analytical skills and attention to detail.
• Collaborative team player with effective communication across multidisciplinary teams.

This is a unique opportunity to join an innovative medical technology company operating at the intersection of AI, surgery, and digital health. You will play a key role in shaping regulatory strategy for high‑impact clinical technologies, helping bring advanced surgical solutions safely to patients.

Mid‑Senior level

Full‑time

Quality Assurance

Staffing and Recruiting and Medical Equipment Manufacturing