About the position
HelloBetter is a pioneer in digital healthcare, developing evidence-based digital health applications for mental health conditions. The company is seeking a Regulatory Affairs Manager to act as a 'door opener' rather than a 'gatekeeper'. This role is crucial for ensuring that digital products treating real patients are compliant, with the understanding that compliance is not just a checkbox but essential for patient care. The ideal candidate will be able to maintain rigor regarding Medical Device Regulation (MDR) and effectively communicate regulatory requirements to various stakeholders, including engineers, founders, and customers. The role involves transforming complex regulatory documents into actionable plans and fostering team-wide understanding of regulatory requirements.
Responsibilities
• Own the ongoing conformity of software as a medical device with risk class I under MDR (Regulation (EU) 2017/745) and the MPDG.
• Maintain and evolve the Integrated Management System and related Technical Documentation, ensuring audit-readiness and adaptability to regulatory changes.
• Maintain and sharpen the ISO 13485 quality management system, ensuring alignment with international standards (EN 62304, ISO 14971, EN 62366) and usability for the entire team.
• Run Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) end-to-end, including monitoring incidents, driving CAPAs, and handling reporting obligations.
• Lead internal and external ISO 13485 audits, participate in ISO 217001 audits, and manage the closure of findings.
• Track upcoming regulations (AI Act, DiGAV amendments, BSI guidelines), translate their implications for the company, and advise product, engineering, and clinical teams.
• Support the Research team with fast-track applications under Sec. 139e SGB V / DiGAV, drive preliminary-to-permanent listing conversions, and act as a secondary contact for BfArM.
• Actively use AI tools to accelerate technical documentation, audit preparation, and regulatory processes like Supplier Management.
• Bring the Regulatory Affairs setup to a faster, leaner, and more effective level.
Requirements
• A completed degree in a relevant field (life sciences, engineering, law, health sciences, or similar).
• 2+ years of hands-on working experience with MDR, ISO 13485, or DiGAV, with practical application to a device.
• Fluent English (written and spoken).
• Comfort working within agile development environments.
• The ability to translate regulations into actionable one-page plans for the team.
• Practical fluency with AI tools for regulatory and QMS work.
• A track record of owning an audit or certification process from preparation through closure.
Nice-to-haves
• German language proficiency.
• Experience within a digital health startup.
• Prior exposure to SaMD/DiGA-specific submissions rather than 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 evidence of engineer engagement.
Benefits
• 25-40 hours per week.
• Salary range: Junior (IC L1): 49k-57k EUR + VSOP (one-time, 5% of yearly salary) or Mid-level (IC L2): 60-72k EUR + VSOP (one-time, 10% of yearly salary).
• Remote-first culture with offices in Berlin, Hamburg, and Potsdam.
• Meaningful work in mental health.
• Opportunity to be at the forefront of digital health research and innovation.
• Emphasis on personal growth and employee development.
• Flexible working hours.
• Company language is English.
• Transparent salary bands.
• Additional 10 paid leave days for non-birth parents.
• 28 vacation days + compensation for holidays falling on weekends.
• Tenure-based paid time off.
• Permanent employment contract.
• Attractive VSOP (Virtual Stock Option Plan) for all employees.
• Tax-deductible pension plan with above-average employer contribution.
• Free or subsidized fitness memberships.
• Regular team events.
• Relocation option and support.