Regulatory Affairs Manager

You own the ongoing conformity of HelloBetter's software as a medical device with MDR and maintain our Integrated Management System and Technical Documentation. You are responsible for CE marking, QMS governance, post-market surveillance, audit leadership, regulatory tracking, DiGA listing support, and AI-accelerated regulatory operations.

What you'll do

• Own the ongoing conformity of our software as a medical device with risk class I under MDR and maintain and evolve our Integrated Management System and Technical Documentation
• Maintain and sharpen our ISO 13485 quality management system and keep us aligned with international standards including EN 62304, ISO 14971 and EN 62366
• Run post-market surveillance end to end: monitoring incidents, driving CAPAs to actual closure, and handling reporting obligations to competent authorities
• Lead our internal and external ISO 13485 audits and partake in ISO 27001 audits, responsible for closing all findings
• Track upcoming regulatory changes and translate them into what they mean for us, advising product, engineering, and clinical teams
• Support the Research team with fast-track applications under DiGAV, drive preliminary-to-permanent listing conversions, and act as secondary point of contact for BfArM
• Use AI tools to speed up technical documentation, audit prep, and regulatory processes

What you'll need

• A completed degree in a relevant field (life sciences, engineering, law, health sciences, or similar)
• 2+ years hands-on working experience of MDR, ISO 13485, or DiGAV with applied regulatory experience
• Fluent English (written and spoken); German is a strong plus
• Comfortable working inside agile development and able to read a sprint board
• The ability to turn a regulation into a one-page action plan every other person can execute
• Practical fluency with AI tools for regulatory and QMS work
• A track record of owning an audit or certification process from prep through closure

Nice to have

• Experience inside a digital health startup
• Prior exposure to SaMD/DiGA-specific submissions rather than device hardware regulatory paths
• Familiarity with EN 62304, ISO 14971, EN 62366, ISO 27001 or BSI TR-03161
• Experience building or improving a QMS from the inside with proof of engineers actively engaging with it

What they offer

• Salary: 49k-57k EUR (Junior) or 60-72k EUR (Mid-level) plus 5-10% one-time VSOP
• Remote-first culture with offices in Berlin, Hamburg and Potsdam
• 25-40 hours per week, flexibly structured
• Start date: November 2026