Regulatory Affairs & Quality Assurance Officer

Signatur Biosciences — Regulatory Affairs & Quality Assurance Officer

London, UK · Full-time · With travel to our laboratory in Liège, Belgium · Reporting to the Head of Regulatory Affairs & Quality Assurance

Company

Today, precision medicine coupled with advanced diagnostics is taking over.

However, those innovations in medicine come with an ever-increasing price tag driven by more expensive and complicated solutions making them less accessible unless we do something about it.

Signatur Biosciences was established with the mission of making cutting-edge diagnostic tools accessible to more patients around the world.

As a startup we have developed a technology to profile complex molecular signatures in a single reaction using q PCR machines already in place in every biomedical lab around the world.

We are a spin‑out of Imperial College London, backed by Y Combinator, with our head office in London and our laboratory in Liège, Belgium.

We’re worried about accessibility in precision diagnostics and are building a team of individuals who share our passion for solving this problem through close collaboration and a sense of urgency.

We’re building a different kind of company, where employees think like owners, act with authority, and collaborate closely with one another.

About the role

This is a hands‑on entry point into regulatory affairs and quality assurance in the medical device / IVD sector, and it is deliberately pitched at someone early in their career.

Under the responsibility of the Head of RAQA, you will take day‑to‑day ownership of defined regulatory and quality activities that underpin the development and manufacturing of our q PCR‑based diagnostic kits.

You will be directly mentored by the Head of RAQA and will build genuine, practical exposure to how an IVD company operates under ISO 13485 and IVDR, and, as we expand, US FDA requirements.

We are a team of sixteen.

In a company of our size you are not on the edge of the regulatory function — you are a third of it.

You will be in the room for audits and technical documentation from early on, and we expect a strong performer in this role to progress to RAQA Specialist quickly.

The role is highly cross‑functional and requires strong organisational skills, attention to detail, and the ability to work collaboratively across Laboratory Operations, R&D and Manufacturing.

• Main responsibilities
• Quality & audit readiness
• Support internal and external audits: gathering evidence, organising documentation, and tracking actions through to closure.
• Support the non‑conformity and CAPA log: logging, follow‑up, status updates, and escalation of actions that fall overdue.
• Support supplier qualification and evaluation records: obtaining certificates, tracking renewal dates, and flagging gaps.
• Support Computer System Validation activities for QMS and lab software tools by drafting and formatting validation documentation.
• Contribute ideas for the continuous improvement of QMS processes, templates and ways of working.
• Help prepare inputs for the internal audit programme and management review.
• Documentation & document control
• Draft, format and update SOPs, Work Instructions, Forms and templates, under the review of the Head of RAQA.
• Own the document control trackers — review cycles, approval status, training records — and flag items coming due.
• Own the training records and onboarding documentation for new team members.
• Help maintain the QMS document and record archive in line with applicable retention requirements.
• Regulatory affairs
• Support the compilation, formatting and cross‑referencing of technical documentation for IVDR conformity.
• Run our regulatory‑intelligence watch: monitor news, guidance updates and standards changes, and brief the team on what they change for us.

Essential skills and experience

• Bachelor’s or master’s degree in a life‑science field (e. g. biology, pharmacy, biotechnology, biochemistry) or a related discipline.
• Fluent in English, written and spoken, and a precise writer — much of this role is making complex requirements unambiguous on paper.
• Strong attention to detail and a methodical, organised approach to documentation.
• A quick learner, comfortable picking up new topics, tools and processes with limited handholding.
• A self‑starter who takes initiative and follows tasks through to completion.
• A clear interest in building a career in regulatory affairs and quality.
• Comfortable working in a small, fast‑paced start‑up environment with shifting priorities.
• Willing to travel to our laboratory in Liège, Belgium.

Desirable skills and experience

• Experience, including an internship or placement, in a medical device or IVD company, or an equivalent regulated environment.
• Prior exposure to quality or regulatory concepts through coursework or previous experience (e. g. ISO 13485, IVDR/MDR, Gx P).
• Working knowledge of French — the working language of our Liège site — or another second language.
• Confident use of AI tools to accelerate documentation and research tasks.
• Familiarity with q PCR workflows or molecular biology laboratory environments.
• What we look for
• Curiosity and fast learning

— picks up new concepts quickly, seeks and applies feedback, and is interested in the “why” behind a requirement, not just the “what”.

Attention to detail

— produces accurate, well‑organised documentation, checks their own work, and flags inconsistencies proactively.

Sense of urgency and focus

— recognises what needs immediate attention and acts, sets priorities, and manages time well.

Teamwork and communication

— communicates clearly across functions, is dependable, and asks for help rather than getting stuck.

Ownership and initiative

— treats an assigned area as genuinely their own, and raises problems early with a proposed solution.

• Competitive base salary — compensation will be based on experience level against the qualifications above.
• Share options, subject to the terms of our employee share option plan.
• Direct one‑to‑one mentoring from our Head of RAQA, and a defined path to RAQA Specialist.

As we continue to grow, our benefits package may evolve. The benefits outlined above are accurate as of the job posting date, but may differ at time of hire.

Signatur Biosciences is an equal‑opportunity employer promoting diversity and inclusion in the workspace.

We do not discriminate on the basis of race, colour, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law.

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