About OpenRegulatory
What is OpenRegulatory?
OpenRegulatory is a Berlin-based healthcare-regulatory consultancy and software business that helps startups bring medical devices to market. Founded by Dr. Oliver Eidel and run as OpenReg GmbH, it has been on the market for over six years, passed EU MDR, FDA, and Health Canada audits with thousands of customers, and is 100% bootstrapped — no investors. The company publishes its full library of compliance document templates (ISO 13485, IEC 62304, ISO 14971, IEC 62366) for free on GitHub as part of a "make medical device compliance transparent, accessible and free" mission. Its flagship product, Formwork, is an AI-powered eQMS that replaces Google Drive / Jira / Sharepoint with a purpose-built tool — ISO 13485 & EU MDR ready out-of-the-box, with real-time completeness checks and audit-proof e-signatures compliant with FDA 21 CFR Part 11. Pricing starts from €99. The company also operates a side-project digital-health job board (Digital Health Jobs) and writes openly on its blog about compliance economics, sustainability, and small-team philosophy.
Where will I work?
OpenRegulatory is fully remote and distributed across Europe and beyond — the current team of four spans Germany (founder Dr. Oliver Eidel and consultant Sebastian Skorka), Spain (developer Ale Solano), and India (developer Saurabh Sikchi). Past team members include consultants from Moldova (Nicoleta Spinu) and Germany (Sören Hornof, Sven Piechottka). The company is registered as OpenReg GmbH in Germany but the working pattern is "set your own goals, work hours, and working at your own pace" — there is no central office.
What is the OpenRegulatory team like?
Small, intentionally so. The /join_us page is explicit that the company is "100% bootstrapped" with the strategy of staying small and serving customers (healthcare startups) that don't have a lot of money. Two named external advisors give the team senior subject-matter reach: Prof. Dr. Alexander Radbruch, Director of the Department of Neuroradiology at University Hospital Bonn, who researches AI applications in radiology and trained in both Medicine and Law at Heidelberg, Munich, and Baylor College of Medicine; and Qing Guan, a Product Advisor whose career spans King (Candy Crush), N26 (one of Germany's first neobanks), and Ada Health (AI-based disease diagnostics). The hiring philosophy is the gold-standard small-team manifesto: "We don't micro-manage. We hardly manage at all. We discuss which projects you'll be working on and the rest is up to you… We don't use Slack… We only expect you to reply within 24 hours on work days — no online indicator needed." And: "If you can be profitable working two hours a day — awesome! Spend the other 22 hours however you like."
Work-Life Balance
The /join_us page is one of the most directly worded 4DW manifestos in the directory: "A four-day workweek. Regulatory consulting can be exhausting. We switched to a four-day week before it was cool. Fridays are off." The four-day week sits inside a broader anti-burnout operating model: "I consistently work less than 40 hours per week. Evenings and weekends are off-limits for business communication. I'm a big fan of DHH and Basecamp books like It Doesn't Have to Be Crazy at Work." The company runs on just one synchronous meeting per week — Monday morning, by voice — and everything else lives in Basecamp asynchronously. Push notifications are explicitly discouraged: "Turn notifications off. If you're in the mood for work, log in to Basecamp or open your inbox; otherwise, stay focused on life." The combination — no Slack, Fridays off, one meeting a week, no online-status indicator, work-when-you-want — adds up to one of the deepest async-cultures on the directory. The vacation policy is unlimited.
Perks and Benefits
Verbatim from the /join_us page:
- A four-day workweek — "We switched to a four-day week before it was cool. Fridays are off."
- Unlimited vacation — set your own time off
- 25% profit share — "We share 25% of our profits among all team members" as a bonus on top of salary
- Full salary + bank-account transparency — every team member gets read-only access to the company bank account and can see all salaries, bonuses, and expenses
- Company credit card with no purchasing process ("If you need something, just buy it") plus an Amazon Business login for work supplies
- Fully remote, work from anywhere, set your own hours
- One meeting per week (Monday async) — everything else in Basecamp
- No Slack, no online indicators, no push notifications expected — 24-hour reply expectation on work days
- Bootstrapped, profitable, run by grown-ups — no 60-hour weeks, no constant pivots, no micromanagement
- Mission-driven — helping healthcare startups ship faster