Regulatory Affairs

Reporting to the Head of Regulatory Affairs & Quality Assurance

About Signatur Biosciences

Signatur Biosciences is making precision diagnostics more accessible. We develop technology that profiles complex molecular signatures using qPCR equipment already found in biomedical laboratories. We are a spin‑out of Imperial College London, backed by Y Combinator, with a team of about sixteen in Liège and London. Our laboratory is in Liège, and this role is based there.

We are building a team that takes ownership, works closely across disciplines and finds better ways to get things done.

About the role

This is a hands‑on RAQA role for someone early in their career who wants to grow fast. You will take over the day‑to‑day running of our quality management system from the Head of RAQA: document control, training records, CAPA, audit preparation. Then you will make it simpler and automate the repetitive parts. Within 12 to 18 months, we want you owning the QA side of the QMS and growing into an RAQA manager role, so the Head of RAQA can focus on our regulatory submission.

We want someone who challenges the status quo. Ask "why does this step exist?" about every procedure. Is it actually required by the standard, or is it habit? Can fifty steps be four? Then propose the simpler version and make the case for it. Lean, never non‑compliant: the minimum compliant version, with the records an auditor needs. The Head of RAQA decides; you bring the better way. If you prefer to follow procedures exactly as you find them, this role is not for you. We work with AI every day, in every role, and we move fast. If you already use AI to automate your own work, not just to polish your writing, you will fit in here.

This is not a back‑office job. You will sit in the audit room and answer the auditor yourself. You will work directly on what takes a diagnostic product to market in Europe: our IVDR submission for CE marking and our ISO 13485 certification, both in progress now. In a team this small, you learn fast and carry real responsibility from the first month. If you want a career in regulatory affairs and quality, it is hard to find a better springboard.

The role is based at our laboratory in Liège, on site most days, with some hybrid working. You will travel to London from time to time. Relocation to Liège welcome.

We work in English and French. Our documents are in English and half the team does not speak French; French is the everyday language of the lab. You need both.

Main responsibilities

• Maintain document-control trackers, approval status, training records and onboarding documentation. Make upcoming deadlines and missing evidence visible.
• Keep non-conformity and CAPA records up to date, follow up actions and elevate overdue items or unresolved issues.
• Support supplier qualification and evaluation records, tracking renewals, approvals and gaps.
• Prepare evidence and documentation for internal and external audits, quality trend reporting and management review.
• Review and approve IVD product batches for release, ensuring they comply with established acceptance criteria.
• Draft and update SOPs, work instructions, forms and templates under the review and approval of the Head of RAQA.
• Contribute to IVDR quality-system expansion, technical documentation, labelling and instructions for use. Programme ownership and regulatory approval remain with the relevant senior reviewers.
• Support validation documentation for quality and laboratory software tools under supervision.
• Monitor relevant regulatory guidance and standards, and explain their practical implications to the team.
• Improve repetitive administrative and documentation work using AI, reusable skills and simpler processes. Check outputs against sources and preserve required quality controls.
• A university degree at least at undergraduate level, with relevant scientific or technical grounding. Life sciences, biology and engineering are preferred.
• Between one and five years of hands‑on QA work in an ISO 13485 environment, ideally IVD (in vitro diagnostics).
• Working English and working French, spoken and written, and the ability to turn complex information into clear instructions.
• Reliable handling of records and deadlines, with attention to detail and evidence of completing work accurately.
• Initiative, quick learning and willingness to seek and apply feedback.
• Motivation to do routine document control and quality administration alongside regulatory work.
• Confident practical use of ChatGPT, ChatGPT Work or Claude Cowork beyond ordinary chatbot conversations: creating projects with appropriate context and instructions, using authorised connectors, and creating or improving reusable skills.
• A habit of challenging the status quo constructively: aski