Senior Compliance Manager – Quality & Regulatory Affairs / QMB ISO 13485 (m/f/d)

Whether the role of PRRC (Person Responsible for Regulatory Compliance) becomes part of the function will be discussed together during the selection process – depending on your qualification and a clear agreement on responsibilities.

The biggest challenge? Making regulatory requirements understandable across the company – explaining why something is necessary rather than just distributing guidelines – and actively engaging colleagues both in the office and remotely.

What you should bring

• You have at least three years of relevant experience in the medical device field and know MDR and ISO 13485 from practical experience. You want to bring your QM/RA experience into a dedicated QMB role – or already bring it with you.
• You have prepared, accompanied, and followed up on audits. Having independently managed an audit is a plus – as is experience with internal audits.
• You bring genuine technical understanding: You know how software development works (frontend vs. backend, releases, tickets) without needing to code yourself. A background in hardware or implants is welcome if your tech affinity is right.
• You are ready to assume the QMB role according to ISO 13485.
• You work in a structured, thorough, and independent manner, actively approach colleagues, and follow up when input is missing. You can say "No, that won't work" – while simultaneously finding pragmatic, risk-based solutions that Engineering and Product can work with.
• You have very good German skills (at least C1) to reliably understand and communicate German DiGA regulations, and very good English skills for collaborating with our engineering team.
• A plus, but not a requirement: Experience with DiGA or Digital Health, SaMD (Software as a Medical Device), ISO 27001 / ISMS or BSI certifications, as well as knowledge of Confluence, Jira, or Matrix Requirements.

What to expect at Vivira

• Ownership:  You independently design the QMS – your own processes, high freedom, short decision-making paths.
• Career Leap:  Your own QMB responsibility covering a broad spectrum including MDR, DiGA, ISO 13485, ISO 27001, and BSI – built on an established system with a planned handover.
• Workplace:  Hybrid in Berlin with 1–2 days per week in the office. Travel occurs only occasionally (under 10%).
• Working Abroad:  Up to one month per year, you can work from within the EU, EEA, Switzerland, Israel, or the UK.
• Recharge:  30 vacation days for true breaks.
• Health:  Our app for your own back health.
• Securing the Future: Increased employer contribution to the company pension scheme.
• Corporate Benefits:  Exclusive benefits for shopping, tech, and more.
• Referral Bonus:  Every successful recommendation from your network is rewarded.
• Highlights:  Multiple company and team events per year – and a dedicated team.

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Source: Statistisches Bundesamt (Destatis), table; dl-de/by-2-0; StarIn's calculation