Regulatory Affairs Manager / PRRC (m/f/d)

Cancilico; Dresden; Hybrid; EUR 55.000 - 70.000; Vollzeit

Benefits dieser Stelle

Hybrid in Dresden

Flexible core hours (10:00–15:00)

Training in auditor qualification and,

Zusammenfassung

Cancilico, based in Dresden, seeks a Regulatory Affairs Manager / PRRC (m/f/d) to lead technical documentation and regulatory strategy for AI-driven diagnostics. You will translate clinical data into regulatory evidence, oversee post-market surveillance, and act as PRRC under IVDR.

Remote collaboration in a small team, with hybrid work in Dresden and German authority interactions. Requirements include a degree in a relevant field, plus regulatory/quality experience, and fluency in German and

Qualifikationen

• Fluent German and English both required.
• Degree in a relevant scientific field plus regulatory experience.
• Experience with IVDR/MDR and notified body processes preferred.
• Strong ability to translate clinical data into regulatory arguments.
• Ability to work in a small team and take ownership beyond core responsibilities.

Aufgaben

• Own our technical documentation and ensure Annex II/III compliance.
• Translate clinical/evidence into regulatory arguments and performance evaluations.
• Manage post-market surveillance, CAPA and risk management inputs.
• Oversee PRRC duties, conformity checks, and ongoing declarations of conformity.
• Define regulatory strategy for device classifications, markets and timelines.
• Provide support during audits, management reviews, and change control.

Kenntnisse

German language

English language

Regulatory knowledge

Quality management systems

Clinical/medical understanding

Ausbildung

Degree in law, medicine, pharmacy, engineering or relevant scientific discipline

Tools

QMS ISO 13485

ISO 27001

eQMS Matrix Requirements

Jobbeschreibung

Regulatory Affairs Manager / PRRC (m/f/d)

Why this role exists

Cancilico is a Dresden-based, seed-funded health-tech company, spun out of TU Dresden and University Hospital Dresden. Our first product, MyeloAID, uses AI to automate the morphological differentiation of bone marrow smears, and we’re expanding into new diagnostic verticals.

Today, we sell multiple products for research use only. Moving into routine diagnostics requires technical documentation that holds up to notified body review, a performance evaluation that convinces clinicians, and a post-market system that keeps the evidence current after launch. You will lead that work and serve as our PRRC under Article 15 IVDR.

What you’ll do

• Own our technical documentation. Writing it is a team effort across engineering, clinical and quality management. You are accountable for meeting Annex II and III and responding to notified body findings.
• Turn clinical expertise into regulatory evidence. Translate Annex XIII into work our hematologists and medical technical assistants, or a CRO where appropriate, can execute. Use the results to write a performance evaluation that holds up.
• Run post-market surveillance. Decide what we need to learn from the field, make sure the data reaches us, review it regularly, and feed the findings into risk management, CAPA and future releases. Do the same for PMPF.
• Act as our PRRC. Oversee conformity checks before release, keep the declaration of conformity current, and meet the surveillance and reporting obligations under Article 15.
• Set regulatory strategy. Decide which regulatory route fits each device, which markets to enter first, what the AI Act adds to the IVDR, and what a US entry would demand. Make the cost in evidence and time clear.
• Deputise for our quality management representative, who will do the same for you. You should be able to step into audits, management review, CAPA, supplier control and change control for a few weeks without the system stalling.

What we’re looking for

Must have

• You meet the PRRC requirements of Article 15 IVDR. Either a degree in law, medicine, pharmacy, engineering or another relevant scientific discipline plus at least one year of professional experience in regulatory affairs or in quality management systems relating to in-vitro diagnostics, or four years of that experience without such a degree. This is the one requirement we cannot be flexible on; everything below it we can build together.
• Hands-on work with the IVDR or MDR: technical documentation, conformity assessment, or a notified body process you were part of rather than adjacent to.
• Comfort with clinical and performance evidence: you can read a study critically and write the argument that follows from it.
• You are comfortable working in a small team and taking ownership beyond your core regulatory responsibilities when needed.
• Fluent German and English.

Nice to have

• Software as a medical device: IEC 62304, IEC 82304, IEC 62366, ISO 14971 applied to software rather than to hardware.
• AI/ML-based devices, and any exposure to the EU AI Act.
• Experience with FDA submissions or requirements, such as 510(k), De Novo or QMSR.
• ISO 13485 internal auditor training, or having sat on the receiving end of a notified body audit.
• A clinical, laboratory, or legal background.
• You use approved AI tools for research, drafting and document review, with sound judgment around confidential and regulated information.

You do not need to have done all of this before. We can fill gaps together, but you should want to build the regulatory argument yourself.

Our setup

• QMS: ISO 13485-based, integrated with ISO/IEC 27001 and GDPR. Matrix Requirements as our eQMS.
• Tooling: GitHub for code, CI/CD and tasks.
• People: you’ll work closely with our quality management representative, Katja, and directly with our leadership team.

What we offer

• Salary: €55,000–€70,000 depending on experience and fit.
• 30 days paid leave, flexible core hours (10:00–15:00).
• The role is available full-time or part-time, from 30 hours per week.
• Pick your machine: Mac, Windows, or Ubuntu.
• Flexible German benefits, negotiable based on your needs.
• Our team works in English. German is required for work with authorities, the notified body and German hospital customers.
• We support relevant training, including auditor qualification and courses on the AI Act or FDA requirements.
• Hybrid in Dresden. You’ll need an existing right to work in the EU; we can’t sponsor relocation or visas at this stage.
• We welcome applications regardless of background, parental status, disability, or neurodivergence.