(Senior) Regulatory Affairs Manager (d/f/m)

General Information

Reports to: Philip Ihde
Department: Operations
Working hours: 25-40 hours per week, ideally
Salary range:

• Mid-level (IC L2): 60-72k EUR + VSOP (one-time, 10% of yearly salary)
• Senior (IC L3): 73-91k EUR + VSOP (one-time, 15% of yearly salary)

Your mission

About HelloBetter

HelloBetter is a pioneer in the field of digital healthcare. For more than 10 years, we have been developing evidence-based digital health applications for the prevention and treatment of mental health conditions. Our applications cover a variety of areas, including stress management, depression, problematic alcohol use, panic disorder and anxiety, vaginismus, and sleep disorders.

Six of HelloBetter's ten applications are approved as digital health applications. They are available free of charge by prescription to all insured adults in Germany.

In 2025, we've additionally launched Ello. Ello is HelloBetter's AI mental wellness companion that provides evidence-based psychological support for everyday mental health challenges like stress, low mood, and difficult life situations. We've combined our 10 years of digital therapeutics expertise with AI technology to make psychological support more accessible.

For more information about HelloBetter, see our HelloBetter Handbook.

Why this role exists

Most Regulatory Affairs job ads describe a gatekeeper. Here you are a door opener. At HelloBetter, our digital products treat real patients, with depression, burnout, insomnia, chronic pain and more, so "compliant" isn't a checkbox, it's the difference between someone getting help or not. For this role, we need someone who can hold the line on MDR rigor on a Monday and explain in one sentence, on a Tuesday, why that rigor makes our product better - to an engineer, a founder, or a customer.

You will be the owning the majority of Regulatory Affairs at HelloBetter. You have stakeholders and support everywhere (product, engineering, clinical, legal, research and leadership), but the field is yours to run and optimise.

So if your idea of a good day is turning a 40-page MDR annex into a one-page decision for the product team, and you get genuinely excited about owning Regulatory affairs end-to-end and getting an entire team on board with regulatory requirements, then please keep reading.

Your objectives

CE marking, for real, not just on paper. You own the ongoing conformity of our software as a medical device with risk class I under MDR (Regulation (EU) 2017/745) and the MPDG. You maintain and evolve our Integrated Management System and the related Technical Documentation, keeping it both audit-ready for a Notified Body and ready for regulatory changes (e.g. MDR amendments, software up-classification).

A QMS people actually use. You maintain and sharpen our ISO 13485 quality management system and keep us aligned with international standards (including EN 62304, ISO 14971 and EN 62366), while upholding usability for the entire HelloBetter Team. It is important to us that team members outside of the Compliance Team can find the information they need fast and easily.

Post-market surveillance that catches things early. You run PMS/PMCF end to end: monitoring incidents, driving CAPAs to actual closure, and handling reporting obligations to competent authorities if required.

Audits you walk into prepared. You lead our internal and external ISO 13485 audits, partake in the ISO 217001 audits, and are responsible for closing all findings. We aim to build a paper trail solid enough to hand a Notified Body the day that relationship becomes necessary.

Regulatory radar, six months ahead. In collaboration with the Legal Counsel: You track what's coming - the AI Act, DiGAV amendments, updated BSI guidelines - translate it into what it actually means for us, and advise product, engineering, and clinical teams on how to build it right the first time.

DiGA listing and the BfArM relationship. You support the Research team with fast-track applications under Sec. 139e SGB V / DiGAV, drive preliminary-to-permanent listing conversions, and act as the secondary point of contact for BfArM. You are someone the Research team can trust to give a straight answer.

AI-accelerated regulatory operations. You actively use AI tools to automate and speed up technical documentation, audit prep, and regulatory processes (such as the Supplier Management). You are responsible for bringing our setup to a faster, leaner and more effective level. From building agents to vibe coding your own small tools; it’s all welcome, as long as it is GDPR-conform and secure.

Your profile

Must Have

• A completed degree in a relevant field (life sciences, engineering, law, health sciences, or similar): we care more about what you can do than your exact major though.
• 3+ years hands-on working experience of MDR, ISO 13485, or DiGAV: you must have applied the regulations to a device already.
• Ownership of regulatory affairs or parts of it end-to-end: You've decided what good looks like, built the processes to get there, and been accountable for the result.
• Fluent English (written and spoken), German is a strong plus given the BfArM and Notified Body correspondence.
• Practical experience building AI tools for regulatory and QMS work: you've previously automated your technical documentation drafts, your summaries of incoming regulation or your audit prep.
• Comfortable working inside agile development: you can read a sprint board, are comfortable with joining a leadership meeting, and know when a feature change triggers a regulatory reassessment.
• The ability to turn a regulation into a one-page action plan every other person at HelloBetter can execute.
• A track record of owning an audit or certification process from prep through closure.

• Experience inside a digital health startup: you know what it's like when the team is smaller than the requirements list.
• 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 from the inside, ideally with proof of engineers actively engaging with it.

• Strong project management instincts: you can run multiple workstreams in parallel without dropping one.
• Sharp analytical and interpretive skills: you read a regulation once and know what it means for us specifically.
• Clear, direct communication: you can explain the same thing to a founder, an auditor, an engineer or someone from Business Development. You are able to adjust your communication to your audience, while upholding the regulatory intent.
• Genuinely good at problem-solving under ambiguity: Certain regulatory amendments don't come with an implementation guide. When you enter unfamiliar territory, you make sense of scarce information, ask the right people, and turn uncertainty into a workable path forward.

• Make the QMS the easiest system in the company to use, not the most impressive one to audit. Side note: auditors will be impressed by the usability within the company.
• Question the status quo, including your own processes from six months ago.
• Use AI as a force multiplier: if it can make a regulatory process faster, easier, or more valuable, go for it.
• Start every initiative with "how does this create value?": You are a door opener for your team members, a guide in uncertainty and a trusted person for everyone in the company.

• You look for day-to-day direction from someone. You’ll set priorities and own the field end-to-end, with support from stakeholders across the company.
• You haven’t tested AI and automation in your work. We’re looking for someone who has already built a workflow and automated processes / tasks. You don’t need to know everything, but you should bring the drive to go further.
• You prefer to work alone. Much of your impact will come from cross-team collaboration and influencing product, engineering, clinical, legal, research and leadership.
• You do not like fast pace. You’ll need to make decisions quickly, build as you go and work without a fixed playbook or escalation path for every situation.

Why us?

Meaningfulness

• Mental health is a human right: we help thousands of people each month who struggle with depression, stress, insomnia, burnout, and other mental health issues
• Research & Evidence
• We have a unique product and are at the forefront of research in digital health applications
• The effectiveness of our product is continuously evaluated and efficacy studies have been published in international and high-impact journals since 2014
• Data is of great importance to us and we are transparent about our strategy, goals and results.

• As pioneers in the development of applications for various mental health conditions, we are at the forefront of innovation
• We operate in an extremely exciting and emerging market
• We place great emphasis on the personal growth of our employees and actively support their development

• Remote-first culture - we hire globally, considering a time window of +/- 4.5 hours CET
• Use of our offices in Berlin and Hamburg if you prefer to work on-site
• Relocation option and support

• Fair and equal treatment are the standards of our Anti-Harassment Policy
• Flexible working hours - shape your own day
• Company language English, with a strong emphasis on inclusive language
• Transparent salary bands
• Additional 10 paid leave days for non-birth parents after the birth or adoption of a child

• 28 vacation days + compensation for holidays that fall on weekends
• Tenure based paid time off - up to three additional days
• Permanent employment contract
• Attractive VSOP (Virtual Stock Option Plan) for all employees
• Tax-deductible pension plan with an above-average employer contribution
• Free or subsidized fitness memberships
• Regular team events

Interview Process