Medical Devices Regulatory Affairs jobs

Job description

Quality Manager — Medical Devices & Diagnostic Laboratory Startup

Salary: £55,000-£60,000 + EMI option scheme

Contract type: Permanent, on-site

Xgenera is a diagnostic company developing a multi-cancer early detection test and preparing to establish a UK diagnostic service laboratory. We are looking for a hands-on Quality Manager to own and develop our quality systems as we move from R&D and clinical trial execution toward commercial diagnostic testing.

This is a foundational role as an individual contributor. You will maintain and improve our ISO 13485-aligned QMS while building the systems required for an ISO 15189 medical laboratory. You will work directly with the CEO and technical team to create pragmatic, audit-ready processes that support speed, quality, and future accreditation.

You will be expected to write documents, create and improve processes, run quality activities, train the team, prepare for audits, and help make quality part of how the company works every day. This position offers the chance to build quality functions from the ground up with scope to become the long-term quality leader of the company.

Responsibilities

• Own and improve the existing QMS.
• Work with quality and regulatory consultants to build and implement ISO 15189 processes.
• Support ISO 13485 certification readiness.
• Establish internal audit processes and prepare the company for external audits, certification, and future UKAS accreditation.
• Support development of SOPs, document control, CAPA, change control, deviation/nonconformance handling, supplier qualification, and training records.
• Work closely with technical staff to ensure quality by design principles whilst ensuring compliance is practical.

Essential Requirements

• 5+ years in a Quality role in medical devices, diagnostics, clinical labs or another regulated life science environment
• Life science degree
• Demonstratable understanding of ISO 15189
• Practical, risk-based approach to quality.
• Excellent written communication.
• Strong interpersonal skills and ability to work directly with the CEO and technical team to build and improve systems from the ground up.
• Willingness to work in a fast-moving startup environment and an ability to be dynamic and prioritise work accordingly.

Desirable

• Good understanding of ISO 13485
• Experience in a startup, scale-up, or small regulated company.
• Familiarity with molecular workflows, PCR, sample handling, contamination control, or clinical testing environments.

Why work at Xgenera?

At Xgenera, you’ll be part of a team doing something truly unique and exciting: developing and bringing to market a multi-cancer early detection test with the potential to deliver huge societal benefit. As a start-up, we offer the chance to get involved in varied, meaningful work where your ideas, energy and expertise can have a real impact. You’ll join a small team of less than 10 that are ambitious, collaborative and deeply values-led, with integrity, innovation, transparency, compassion and a commitment to shaping a better future at the heart of everything we do. We care about our employees as people, and we’re building an environment where everyone can contribute, grow and be proud of the work they’re doing.

If you think you would be a good fit for this role, please send your CV, cover letter, and a 2-minute video of yourself answering the following questions to Recruitment@Xgenera.com:

1. How do you balance pragmatism and perfectionism?

2. What aspect of Quality do you consider to be the most challenging to build or maintain and why?

3. What do you enjoy doing in your spare time?

Pay: £55,000.00-£60,000.00 per year

Work Location: In person