Company Overview
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
Regulatory Manager – Lead and maintain our Regulatory systems in accordance with applicable medical device standards and regulations, ensuring product quality, safety and performance.
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, 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.
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.
Benefits
* Company pension
* On‑site parking
* Work from home available
Job Type
* Full‑time
* Part‑time
Location
Hybrid remote in Cambridge CB4; work from office as required.
Application
Send your CV to emily@camheartwear.com.
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