Regulatory Affairs Manager

Cambridge Heartwear is a cutting‑edge AI and medical technology company based in Cambridge, pioneering the development of innovative healthcare solutions. Our flagship product, the HeartSense, is a wearable ECG device designed to monitor heart rhythm in real‑time, providing invaluable insights for both patients and healthcare professionals.

Regulatory Manager – Lead and maintain our Regulatory systems in accordance with applicable medical device standards and regulations, ensuring product quality, safety and performance.

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• Lead and execute global regulatory strategies for new product development and product lifecycle activities (e.g., submissions to FDA [510(k)/PMA], EU MDR, and other markets).
  
• Prepare, coordinate and submit regulatory dossiers and license renewals, answering technical inquiries and addressing deficiencies.
  
• Monitor and interpret evolving regulatory requirements and provide guidance to R&D, Engineering, Quality, Manufacturing, Clinical, and Marketing teams.
  
• Manage audits and inspections conducted by regulatory agencies and notified bodies; lead internal compliance reviews and risk assessments.
  
• Maintain regulatory documentation within the QMS; ensure traceability and control of regulatory submissions.
  
• Serve as the primary liaison with regulators and external stakeholders, maintaining strong, professional relationships.
  
• Mentor and supervise regulatory specialists; oversee timelines, deliverables and compliance metrics.
  
• Promote a culture of continuous improvement and quality awareness throughout the organization.
  
• Train and mentor team members in quality practices and regulatory compliance.
  

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• Bachelor's degree in Life Sciences, Quality Assurance or a related field.
  
• Recognised quality certification (e.g., CQE, CQA, Six Sigma or equivalent) is an advantage.
  
• Minimum 5 years of experience in quality assurance/quality management in the medical devices industry.
  
• In‑depth knowledge of ISO 13485, EU Medical Device Regulation (MDR), FDA 21 CFR Part 820.
  
• Experience leading audits (internal and external) and working with notified bodies and regulatory agencies.
  
• Knowledge of SaaMD desirable.
  
• Strong understanding of risk management (ISO 14971), design control, and product lifecycle processes.
  
• Proven ability to manage CAPA, NCRs and quality investigations.
  
• Excellent communication, leadership and organisational skills.
  
• Strong analytical and problem‑solving abilities.
  
• Proficient in using QMS software and Microsoft Office Suite.
  
• Experience working in a fast‑paced, regulated environment with multiple cross‑functional teams.
  
• Hands‑on experience with product registration and technical file compilation.
  
• Working knowledge of MDSAP, UDI, and post‑market surveillance (PMS).
  
• Familiarity with software and digital health technologies used in connected medical devices.
  

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• Salary: DOE
  
• Hours of work can be discussed in interview.
  
• Hybrid working model – will require office work.
  

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• Company pension
  
• On‑site parking
  
• Work from home available
  

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• Full‑time
  
• Part‑time
  

Hybrid remote in Cambridge CB4; work from office as required.

Send your CV to .