Regulatory Affairs Manager

Cambridge Heartwear; United Kingdom; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A cutting-edge medical technology firm based in Cambridge is seeking a dedicated Regulatory Manager. This role involves leading regulatory strategies and ensuring compliance with medical device regulations. The ideal candidate will have a background in quality assurance and at least 5 years of experience in the medical devices industry. Key responsibilities include preparing regulatory submissions, managing audits, and liaising with regulatory agencies. Offering a hybrid working model, this is an opportunity to make a significant impact in innovative healthcare solutions.

Benefits

Company pension

On-site parking

Work from home

Qualifications

• Minimum 5 years of experience in quality assurance or quality management in the medical devices industry.
• In-depth knowledge of ISO 13485, EU MDR, FDA 21 CFR Part 820.
• Proven ability to manage CAPA, NCRs and quality investigations.

Responsibilities

• Lead and execute global regulatory strategies for new product development.
• Prepare and submit regulatory dossiers and license renewals.
• Monitor and interpret evolving regulatory requirements.

Skills

Communication skills

Leadership skills

Analytical skills

Problem-solving abilities

Knowledge of SaaMD

Education

Bachelor's degree in Life Sciences, Quality Assurance or related field

Quality certification (CQE, CQA, Six Sigma or equivalent)

Tools

QMS software

Microsoft Office Suite

Job description

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.

Role

We are seeking a dedicated and detail-oriented Regulatory Manager to lead and maintain our Regulatory systems in accordance with applicable medical device standards and regulations. The ideal candidate will play a critical role in ensuring that our products consistently meet quality, safety and performance requirements, and that our processes align with regulatory standards such as ISO 13485 and MDR.

Responsibilities

• 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, co‑ordinate, 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 organisation.

· Train and mentor team members in quality practices and regulatory compliance.

Qualifications, Skills and Experience

· 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.

Additional Information

· Salary DOE

· Hours of work can be discussed in interview

· Hybrid working model, will require office work

For further informat0ion, or to submit your CV please email [e-mail]

Benefits

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

Experience

• PR: 3 years (preferred)
• Work Location: Hybrid remote in Cambridge CB4