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Salary: EUR 49,000 - 72,000 / annual
HelloBetter is a pioneer in digital healthcare, developing evidence-based digital health applications for mental health conditions including stress management, depression, anxiety, and sleep disorders. Six of their ten applications are approved as digital health applications in Germany and available by prescription. In 2025, they launched Ello, an AI mental wellness companion combining 10 years of digital therapeutics expertise with AI technology.
This Regulatory Affairs Manager role reports to Philip Ihde (Operations) and is positioned as a "door opener" rather than a gatekeeper. The role owns ongoing conformity of HelloBetter's software as a medical device (risk class I) under MDR (Regulation (EU) 2017/745) and MPDG. Key responsibilities include:
**Core Responsibilities:**
- Maintain and evolve the Integrated Management System and Technical Documentation, keeping it audit-ready for Notified Bodies and prepared for regulatory changes (MDR amendments, software up-classification)
- Maintain and sharpen the ISO 13485 quality management system aligned with international standards (EN 62304, ISO 14971, EN 62366), ensuring usability for the entire team
- Run post-market surveillance (PMS/PMCF) end-to-end: monitor incidents, drive CAPAs to closure, handle reporting obligations to competent authorities
- Lead internal and external ISO 13485 audits and participate in ISO 27001 audits, responsible for closing all findings
- Track regulatory developments (AI Act, DiGAV amendments, BSI guidelines) and translate them into actionable guidance for product, engineering, and clinical teams
- Support the Research team with DiGA fast-track applications (Sec. 139e SGB V / DiGAV), drive preliminary-to-permanent listing conversions, and serve as secondary point of contact for BfArM
- Use AI tools to accelerate technical documentation, audit prep, and regulatory processes
The role emphasizes translating complex regulations into one-page action plans, building a QMS that team members actually use, and operating within agile development environments. The exact mix of responsibilities will be adjusted to experience level—junior hires won't own everything from day one but will experience steep learning curves and direct founder exposure.
**Requirements:**
- Completed degree in relevant field (life sciences, engineering, law, health sciences, or similar)
- 2+ years hands-on working experience with MDR, ISO 13485, or DiGAV; must have applied regulations to a device already
- Fluent English (written and spoken); German is a strong plus for BfArM and Notified Body correspondence
- Comfortable working inside agile development; can read sprint boards, join leadership meetings, and recognize when feature changes trigger regulatory reassessment
- Ability to turn regulations into one-page action plans others can execute
- Practical fluency with AI tools for regulatory and QMS work (drafting technical documentation, summarizing regulations, prepping audit evidence)
- 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 (Sec. 139e SGB V fast-track) 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 with proof of engineer engagement
**Operating Style:**
- Strong project management: run multiple workstreams in parallel
- Sharp analytical and interpretive skills; read regulations once and understand specific implications
- Clear, direct communication adaptable to founders, auditors, engineers, and business development
- Problem-solving under ambiguity; turn uncertainty into workable paths forward
- Make the QMS the easiest system to use, not the most impressive to audit
- Question status quo and use AI as a force multiplier
- Start every initiative with "how does this create value?"
Remote-first culture with offices in Berlin, Hamburg, and Potsdam. Working hours 25-40 per week, ideally. Start date November 2026.
