Quality/Regulatory Manager - SaMD

Hobson Prior International Ltd; London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A MedTech organization in London is seeking a Quality/Regulatory Manager to lead the quality and regulatory strategy in ensuring safe and compliant products, particularly in Software as a Medical Device (SaMD). Ideal candidates should have robust experience with ISO 13485 and relevant regulatory frameworks, including UKCA and FDA. This role emphasizes collaboration with clinical and commercial teams to maintain high standards.

Qualifications

• Experience managing an ISO 13485-compliant QMS and leading audits.
• Familiarity with Software as a Medical Device (SaMD) is essential.
• Strong knowledge of UKCA, MHRA, and FDA regulations.

Responsibilities

• Oversee and manage a quality management system that complies with ISO 13485 standards.
• Handle document control and change management audits.
• Lead internal and external audits for inspection readiness.
• Develop regulatory strategies aligned with product goals.
• Manage regulatory submissions, including UKCA marking and FDA registration.

Skills

ISO 13485 compliance

Quality Management Systems (QMS)

Software as a Medical Device (SaMD)

Regulatory submissions (UKCA, MHRA, FDA)

Cybersecurity standards (DTAC, DSPT, DCB)

Job description

Set the standard. Safeguard innovation. Shape digital health.

Hobson Prior is seeking a Quality/Regulatory Manager to join a forward-thinking MedTech organization in London. This role focuses on ensuring the delivery of safe, compliant, and high-quality products and services, particularly in the field of Software as a Medical Device (SaMD). You will lead the quality and regulatory strategy, manage compliance frameworks, and work closely with clinical and commercial teams to maintain excellence.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Oversee and manage a quality management system (QMS) that complies with ISO 13485 standards.
• Handle document control, change management, corrective actions, training records, audits, and supplier oversight.
• Lead internal and external audits, ensuring systems are always ready for inspection.
• Develop and implement regulatory strategies aligned with product and business goals.
• Manage regulatory submissions, including UKCA marking, MHRA Class I-II, FDA registration, and 510(k) processes.
• Maintain technical files and coordinate cross-functional inputs to meet regulatory deadlines.

Key Skills and Requirements:

• Experience managing ISO 13485-compliant QMS and leading audits.
• Familiarity with Software as a Medical Device (SaMD) is essential.
• Strong knowledge of UKCA, MHRA, FDA regulations, and cybersecurity standards such as DTAC, DSPT, DCB, and Cyber Essentials.

For more information, please contact Toby Shelton.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.hobsonprior.com/privacy-policy.