Scipro is a cutting-edge healthcare innovation company based in London.
We are seeking a highly experienced SaMD QARA Manager to lead our quality assurance and regulatory compliance efforts.
The ideal candidate will have strong knowledge of FDA, EU MDR, ISO 13485, ISO 14971, and IEC 62304 regulations.
Key Responsibilities:
* Maintain and improve our Quality Management System (QMS) for Software as a Medical Device (SaMD); support software development life cycle quality controls; manage risk according to ISO 14971.
* Develop regulatory strategies; prepare submissions such as 510(k) and CE Mark; stay updated on regulatory changes; liaise with authorities and notified bodies.
* Partner with R&D, clinical, and product teams to integrate quality and regulatory needs; train teams on industry standards and best practices.
* Enhance QARA processes; monitor and report key performance metrics; support audits, corrective actions, and post-market surveillance.
Requirements:
* Bachelor's degree in Engineering, Software, or related field; at least 5 years of experience in SaMD/medical device QARA; strong knowledge of FDA, EU MDR, ISO 13485, ISO 14971, and IEC 62304.
* Proven track record in regulatory submissions, risk management, project management, and cross-functional collaboration.
* RAC/ASQ CQE certification; cybersecurity and GDPR knowledge; agile development experience.
Estimated Salary: £80,000 - £110,000 per annum, depending on experience and qualifications.