Spectrum.Life
Quality and Regulatory Affairs (QARA) Manager
🇬🇧United KingdomRemote available3 days ago
MidFull TimeEN
Prepare and manage regulatory and quality documentation for CE mark submission and Notified Body reviews.
Coordinate with technical, clinical and other teams, provide tranings and guidance, with support from external CE consultants.
Support the development and maintenance of the Quality Management System (QMS).
Support the preparation and upkeep of the Technical File, including collecting information, compiling evidence, drafting documentation, and collaborating closely with engineering, design, and data teams.
Assist with ISO certification activities (e.g., ISO 13485).
Maintain document control, records, logs, and change control to ensure audit readiness and ongoing compliance.
Act as the main point of contact for consultants and the Notified Body, drafting responses and scheduling audits.
Coordinate requirements, risk, usability, and verification evidence with product, design, and engineering teams.
Contribute to post-market surveillance activities after approval.
Track timelines, prepare status updates, and facilitate cross-team collaboration.
3–6 years of experience in quality, regulatory, or product documentation roles.
Strong ownership, organisation, and documentation management skills.
Technically minded and comfortable working with engineering or product teams.
Degree in engineering or a related technical field.
Experience in digital health, SaMD, or a related regulated technology environment.
Familiarity with ISO certification processes
Experience in UX design, industrial design engineering, or medical device environments.
Clinical experience is useful but not required.
You will be trained and supported by experienced QARA consultants throughout the process.
