Junior Quality & Regulatory Affairs (IVD) - Working Student
Part-time, on-site (Heidelberg)/hybrid
Application Deadline: May 31
QuantiLight is building a diagnostic platform that delivers lab-grade blood test results in minutes at the point of care. The startup’s first clinical focus is therapeutic drug monitoring, beginning with transplant care, with expansion into additional diagnostic and research applications over time.
Based on our strong technology foundation from the Max-Planck Institute, we have built a cutting-edge prototype validated in real care settings and already work with clinics and key opinion leaders, supported by strong partners and grants. We closed our Pre-Seed round in Q2 2026 and are completing the core team bringing the platform to market.
To support the team, we are hiring a Junior Quality & Regulatory Affairs (IVD) - Working Student.
As our first Regulatory & Quality working student, you will work side‑by‑side with the founders and an external Senior Regulatory Expert to support the company’s day‑to‑day regulatory and quality activities - spanning quality management, compliance and clinical strategy.
As a hands‑on generalist who enjoys concrete impact and pays high attention to detail, you will help map QuantiLight’s activities, design initial quality documents from templates and contribute to building our Quality Management System. You will also support the definition of our overarching regulatory and clinical validation approach through literature research and structured interactions with doctors, authorities and CROs, always under guidance.
You will have meaningful responsibility within a clear framework and mentoring. Exposed to critical business areas, you will build valuable hands‑on experience, learning in close contact with the founders and our Senior Regulatory Expert.
In your first month you will mostly work on:
• Regulatory and clinical strategy – Assist founders and Regulatory Expert in defining the overarching regulatory and clinical validation strategy for our product in Europe and USA (e.g. device classification, intended purpose, high‑level pathway options under IVDR and FDA frameworks)
• Drafting initial quality documents – Under the Senior Regulatory Expert guidance, familiarize yourself with our electronic Quality Management System (eQMS) and its templates and generate first documents (e.g. basic SOPs, records, checklists) to share with the team.
• Literature research – Under the Senior Regulatory Expert's guidance, update QuantiLight's scientific literature database and support drafting the State-of-the-Art (SotA) report for internal and external stakeholders
As you grow in the role, you may also:
• Contribute to maintaining and improving QMS documentation aligned with ISO 13485 and IVDR/FDA requirements
• Support preparation of the Technical Documentation (e.g. intended purpose, device description, risk management inputs, clinical/performance evidence summaries)
• Help coordinate analytical and clinical performance studies with CROs and clinical advisors (e.g. document flows, checklists, basic tracking)
• Assist in preparing materials for discussions with Notified Bodies, BfArM, ethics committees and the FDA, always under supervision
• Currently studying towards a Master’s degree in Medical engineering, Biomedical engineering or a related field
• Curious about Quality and Clinical affairs and innovation in MedTech
• Strong observation, analytical and synthesis skills: you can map systems at the macro and micro levels, observing, drafting and refining processes in a structured way
• Open-minded and willing to learn about clinical conditions and regulations in several geographies
• Excellent communication: you can synthesize scientific reports and conversations into clear, concise summaries
• Comfortable using modern collaboration, research, and communication tools (e.g., Slack, Google Workspace, Canva, Notion), as well as traditional software platforms such as Microsoft Office and Adobe
• Startup, regulatory consultancy or quality/clinical experience is a strong plus
• Experience with MDR/IVDR, ISO 13485, ISO 14971 or clinical research (GCP) is a plus
• Fluency in English required. Knowledge of German and/or French (B2+) is a plus
• Legal right to work in Germany (no visa sponsorship possible with this role)
• A strong personal growth opportunity with mentoring from the founders and Senior Regulatory Expert
• Low-risk, flexible exposure to Quality and Clinical affairs, at the heart of an exciting IVD startup
• Part-time (up to 12 hrs/week, 20 €/hr gross salary)
• Opportunity to increase working time (e.g. to approximately 50%) after 6–12 months based on performance and company needs
• A clear path towards a permanent Quality & Regulatory Affairs position after graduation, with potential to evolve into more senior roles (e.g. PRRC or Head of QA/RA) alongside experienced regulatory leadership
• Flexible work arrangement: in-person (Heidelberg, Germany) or hybrid, to be discussed. Fully remote is not possible.
QuantiLight is committed to an inclusive workplace and welcomes applications from qualified candidates regardless of background.
Tell us a bit more about yourself
1/ What excites you specifically about QuantiLight's mission and this role? (max 500 characters)
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2/ Please give a concrete example of when you mapped a system end-to-end (observation, draft, refinement) in a previous role or project. What was the result and what challenges did you face? (max 800 characters)
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3/ Please give a concrete example of your previous experience in Quality affairs, Clinical affairs or compliance. What was the result and which tools did you use? If you do not yet have direct experience, describe another situation where you worked with strict rules or standards. (max 800 characters)
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4/ Please describe your experience with literature research. What was your key result? (max 800 characters)
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5/ What does success look like to you in 3 months, 12 months and 3 years? (max 800 characters)
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6/ Is there something that we should know about you? (max 500 characters)
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