Job Title: SaMD QARA Manager
Location:
London, UK
Estimated Salary:
+60,000 - +90,000 per annum
Job Summary
We are seeking a highly experienced SaMD QARA Manager to lead quality assurance and regulatory compliance for our digital health client based in London. The successful candidate will be responsible for maintaining the Quality Management System (QMS), ensuring adherence to ISO 13485 and IEC 62304 standards, and managing regulatory submissions for FDA and EU MDR.
Key Responsibilities
* Maintain and improve QMS for Software as a Medical Device (SaMD); support Software Development Life Cycle (SDLC) quality controls; manage risk according to ISO 14971; oversee testing and validation protocols.
* Develop regulatory strategies; prepare submissions (e.g., 510(k), CE Mark); stay updated on regulatory changes; liaise with authorities and notified bodies.
* Partner with Research and Development, Clinical, and Product teams to integrate quality and regulatory needs; train teams on standards and best practices.
* Enhance QARA processes; monitor and report metrics; support audits, Corrective Action Preventative Actions (CAPAs), and post-market surveillance.
Requirements
* Bachelor's degree in Engineering, Software, or related field; minimum 5 years of experience in SaMD/medical device QARA; strong knowledge of FDA, EU MDR, ISO 13485, ISO 14971, and IEC 62304.
* Regulatory submissions, risk management, project management, and cross-functional collaboration skills.
* RAC/ASQ Certified Quality Engineer (CQE) certification; knowledge of cybersecurity and GDPR; agile development experience.