Quality and Regulatory Affairs (QARA) Manager at Spectrum.Life

Manchester, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

10 Aug, 26

Salary

0.0

Posted On

12 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, Regulatory Affairs, CE Mark Certification, ISO 13485, Technical File Documentation, Post-market Surveillance, Risk Management, Usability Engineering, Verification Evidence, Document Control, Audit Readiness, SaMD Compliance

Industry

Mental Health Care

Description

About us: Spectrum.Life is a whole-of-health digital partner that guides organisations and their people to thrive, delivering clinically backed digital health, mental health and wellbeing solutions. Our HealthTech delivers digital transformation for Insurers, Educators and Employers through Co-creation or seamlessly integrated out-of-the-box solutions, that decrease digital fragmentation and engage, empower, and transform their people’s lives. Established in 2018 by Stuart McGoldrick and Stephen Costello, Spectrum.Life provides services internationally to over 7.2m insurance members, 3,000 corporate clients, 60 universities and 650,000 university students. Spectrum.Life currently employs over 350 people. Our vision is to change and save as many lives as possible. Role Brief: We are looking for a Quality and Regulatory Affairs (QARA) Manager to support our CE mark certification process and ongoing quality management activities. The role involves preparing and managing QMS, documentation for submission to the Notified Body, coordinating with consultants and internal teams, and supporting audits and compliance after certification, all for AI product that provides users seamless mental health care experience Responsibilities: 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. Requirements: 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 Desirable: 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. What are the benefits of working at SPECTRUM.LIFE? Full-time permanent contract Competitive salary (dependent on experience) In-office, remote or hybrid working options 25 days of annual leave 24/7 EAP and a wide range of health and wellbeing supports Extensive list of employee perks and benefits https://app.box.com/s/6wwkvowbev6cn7tlvq9yz32amnpmnvcl Your profile

Responsibilities

Manage the CE mark certification process and maintain the Quality Management System for an AI mental health product. Coordinate with internal teams and external consultants to prepare technical files and ensure ongoing regulatory compliance.