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

IntroBack problems are the most common reason for inability to work in Germany. Vivira has the solution: digital exercise therapy via app – always available, simple, effective, and reimbursed by health insurance. Behind every application permanently listed in the DiGA directory stands a robust quality management system. That is exactly why we are looking for you: As Senior Compliance Manager, you will take on the role of Quality Management Representative (QMB) according to ISO 13485 and keep our medical devices MDR-compliant – from the next audit to the inclusion of further products in the DiGA directory. Your responsibilities includeAs Senior Compliance Manager (m/f/d), you will be responsible for our quality management system and take on the role of Quality Management Representative according to ISO 13485. You report directly to our Team Lead Compliance and work closely with Engineering and Product. • QMS & Regulatory Affairs: You monitor compliance with DiGAV, MDR, ISO 13485, and ISO 27001, contribute to our BSI certification topics, and develop processes, SOPs, and Work Instructions pragmatically and based on risk. • Technical Documentation: You create and maintain the Technical Documentation according to MDR (DHF/DMR) for our three medical devices – one app listed in the DiGA directory and two CE-marked products in DiGA studies. • Audits: You prepare and follow up on external audits with the notified body, and plan and conduct internal audits. Your first milestone: the ISO 13485 recertification audit in February 2027 – with a stable system, complete documentation, and a planned handover by your predecessor. • Releases & Post-Market Surveillance: You review and approve release documentation and are responsible for post-market surveillance of our products. • Supplier Management: You evaluate and monitor our software providers (e.g. Atlassian, HubSpot, Google) according to criticality. • Regulatory Radar: You evaluate regulatory changes monthly and derive concrete measures. • Interface within the Company: You are the primary contact for regulatory questions across all departments – from Doctor Success to Patient Success –, train colleagues, and proactively gather input. 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. Find Jobs in Germany on Arbeitnow