Regulatory Affairs & Quality Assurance Officer

Signatur Biosciences Ltd; Luik; Hybrid; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Mentoring from Head of RAQA

Relocation support to Liège

Job summary

Signatur Biosciences Ltd in Liège, Belgium, seeks an early‑career RAQA professional to run day‑to‑day quality management tasks and drive improvements with AI. You will eventually own QA within the QMS and grow toward RAQA management as the Head of RAQA focuses on regulatory submissions.

You will work on-site most days with some hybrid options, and occasional travel to London. The role requires English and French proficiency and a proactive, process‑oriented mindset.

Qualifications

• A university degree at least at undergraduate level, with relevant scientific or technical grounding.
• Between one and five years of hands‑on QA work in an ISO 13485 environment, ideally IVD.
• Working English and working French, spoken and written, and ability to turn complex information into clear instructions.
• Confident practical use of modern AI tools to automate repetitive tasks while maintaining quality controls.

Responsibilities

• Maintain document‑control trackers, approval status, training records and onboarding documentation.
• Keep non‑conformity and CAPA records up to date, follow up actions and escalate overdue items.
• 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 compliance with criteria.
• Draft and update SOPs, work instructions, forms and templates under Head of RAQA.

Skills

English & French

Attention to detail

Initiative

QA in ISO13485

AI automation

Education

Bachelor's degree

Tools

ChatGPT

Claude Cowork

Job description

Liège, Belgium · Full-time · Permanent contract (CDI) · On site, some hybrid · Early career · Competitive salary

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 **escalate** 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.

Essential capabilities

• 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: asking why a step exists, separating what a standard actually requires from habit, and proposing the simpler version.
• A proactive mindset towards automating repetitive work with AI. You must be able to check results, spot errors and keep necessary human review in place.
• Able to work on site at our Liège laboratory most days, with occasional travel to London. Relocation to Liège welcome.

Background and experience

This is an early‑career role, not an entry‑level one. You need between one and five years of hands‑on quality assurance work in an ISO 13485 environment: an IVD or medical‑device company, or a supplier working under an ISO 13485 quality management system. IVD experience counts most. Experience only in other regulated settings (an ISO 15189 or ISO 17025 accredited laboratory, or GMP or GLP quality assurance) is not enough on its own for this role. An internship or placement counts towards the year only if it was real QA work inside an ISO 13485 system.

This role is unlikely to suit you if your career so far has been mainly in the pharmaceutical industry: as a guide, more than about a year. We are building a lean quality system for a small diagnostics company, and we want people who will shape it with us rather than bring a big‑pharma one with them. If you moved from pharma into medical devices, ISO 13485 or IVD work, we would still like to hear from you. A pharmacology or biomedical science degree on its own is not pharma experience.

Experience with medical devices or IVDs, IVDR/MDR concepts, molecular biology or qPCR workflows is useful. Claude Code, a more developed personal AI stack, coding and deeper systems integration are additional strengths; this is not an AI engineering role.

What we offer

• A permanent Belgian employment contract and a competitive salary, reflecting the role and your experience.
• Direct mentoring and review from the Head of RAQA.