{"id":1851401,"url":"https://alion.io/job/hellobetter-junior-regulatory-affairs-manager-dfm","title":"(Junior) Regulatory Affairs Manager (d/f/m)","company":{"id":1883173,"name":"HelloBetter","domain":"hellobetter.de","url":"https://alion.io/company/hellobetter","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Personio","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":"full_time","work_mode":"remote","remote_scope":"worldwide","remote_scope_basis":"posting_text","remote_working_hours":{"label":"CET","utc_offset_min":1,"utc_offset_max":1},"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":49000,"max":57000,"currency":"EUR","period":"year","gross":null,"usd_annual":64166},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Agile","optional":false},{"name":"CAPA","optional":false},{"name":"EU AI Act","optional":false},{"name":"ISO 27001","optional":true}],"status":"live","first_seen_at":"2026-09-15T19:16:18Z","employer_posted_date":"2026-09-15","last_verified_at":"2026-10-31T22:33:34Z","board_verified":true,"closed_at":null,"days_open":46,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":46},"description":"General Information\nReports to: Philip IhdeDepartment: Operations\nWorking hours: 25-40 hours per week, ideally\nSalary range:\nJunior (IC L1): 49k-57k EUR + VSOP (one-time, 5% of yearly salary)\nMid-level (IC L2): 60-72k EUR + VSOP (one-time, 10% of yearly salary)\nStart date: November 2026Remote Policy: Remote-first culture with offices in Berlin, Hamburg and Potsdam\nYour mission\nAbout HelloBetter\nHelloBetter 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.\nSix 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.\nIn 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.\nFor more information about HelloBetter, see our HelloBetter Handbook.\nWhy this role exists\n\nMost 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.\nIf 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 by getting the entire team onboard of regulatory requirements, then please keep reading.\nYour objectives\n 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.\nPost-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.\nAudits 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.\nRegulatory 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.\nDiGA 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.\nAI-accelerated regulatory operations. You actively use AI tools to speed up technical documentation, audit prep, and regulatory processes (such as the Supplier Management). You are responsible for bringing our RA setup to a faster, leaner and more effective level.\nYour profile\n Must HaveA 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.\n2+ years hands-on working experience of MDR, ISO 13485, or DiGAV: you must have applied the regulations to a device already.\nFluent English (written and spoken), German is a strong plus given the BfArM and Notified Body correspondence.\nComfortable 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.\nThe ability to turn a regulation into a one-page action plan every other person at HelloBetter can execute.\nPractical fluency with AI tools for regulatory and QMS work: you use them to draft technical documentation, summarise incoming regulation, and prep audit evidence faster, so you spend your time on judgment calls.\nA track record of owning an audit or certification process from prep through closure.\nNice to Have\nExperience inside a digital health startup: you know what it's like when the team is smaller than the requirements list.\nPrior exposure to SaMD/DiGA-specific submissions (Sec.139e SGB V fast-track) rather than device hardware regulatory paths.\nFamiliarity with EN 62304, ISO 14971, EN 62366, ISO 27001 or BSI TR-03161 \nExperience building or improving a QMS from the inside, ideally with proof of engineers actively engaging with it.\nHow you operate\nStrong project management instincts: you can run multiple workstreams in parallel without dropping one.\nSharp analytical and interpretive skills: you read a regulation once and know what it means for us specifically.\nClear, 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. \nGenuinely 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.\nThe mentality we're hiring for\nMake 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. \nQuestion the status quo, including your own processes from six months ago.\nUse AI as a force multiplier: if it can make a regulatory process faster, easier, or more valuable, go for it.\nStart 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. \nA note on the scope: The exact mix of responsibilities above will be adjusted to your experience level - a junior hire won't own all of this from day one, and we'll shape the role around what you're ready for, but more importantly what you want to grow into. You’ll experience a steep learning curve and direct founder exposure, from day one, regardless of seniority.\nWhy us?\nMeaningfulnessMental health is a human right: we help thousands of people each month who struggle with depression, stress, insomnia, burnout, and other mental health issues\nResearch & Evidence\nWe have a unique product and are at the forefront of research in digital health applications\nThe effectiveness of our product is continuously evaluated and efficacy studies have been published in international and high-impact journals since 2014\nData is of great importance to us and we are transparent about our strategy, goals and results.\nGrowthAs pioneers in the development of applications for various mental health conditions, we are at the forefront of innovation\nWe operate in an extremely exciting and emerging market \nWe place great emphasis on the personal growth of our employees and actively support their development\nRemote-FirstRemote-first culture - we hire globally, considering a time window of +/- 4.5 hours CET \nUse of our offices in Berlin and Hamburg if you prefer to work on-site\nRelocation option and support\nDiversity & InclusionFair and equal treatment are the standards of our Anti-Harassment Policy\nFlexible working hours - shape your own day\nCompany language English, with a strong emphasis on inclusive language\nTransparent salary bands\nAdditional 10 paid leave days for non-birth parents after the birth or adoption of a child\n Other Benefits28 vacation days + compensation for holidays that fall on weekends\nTenure based paid time off - up to three additional days\nPermanent employment contract\nAttractive VSOP (Virtual Stock Option Plan) for all employees\nTax-deductible pension plan with an above-average employer contribution \nFree or subsidized fitness memberships\nRegular team events\nHelloBetter is an equal opportunity employer and encourages applicants of any national origin, gender, sexual orientation, religious background, gender identity, and people with disabilities to applyPrivacy Policy for Applicants\nInterview Process\nScreening interview with People Team (30 mins)\nTake-Home Case Study (2 hours)\nCase Interview with Compliance Team (60 minutes)\nFounder Interview with Philip (45 minutes)","description_format":"text","description_chars":9557,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Flexible schedule"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-04T20:16:24Z"}],"visa":[],"liveness":{"score":22,"band":"cold","label":"Long shot","p_open":1,"p_active":0.605,"p_room":0.36,"age_days":45,"expected_fill_days":25,"reasons":["conf:0","win:tail","crowd:remote,junior"],"computed_at":"2026-10-31T05:58:55Z"},"pay":{"stated_usd_annual":64166,"is_top_pay":false},"html_url":"https://alion.io/job/hellobetter-junior-regulatory-affairs-manager-dfm","json_url":"https://alion.io/job/hellobetter-junior-regulatory-affairs-manager-dfm.json","meta":{"generated_at":"2026-11-01T01:41:58Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":2519,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1883173},"rest":"https://alion.io/mcp/rest/get_company?id=1883173"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhellobetter-junior-regulatory-affairs-manager-dfm"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fhellobetter-junior-regulatory-affairs-manager-dfm"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fhellobetter-junior-regulatory-affairs-manager-dfm"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/hellobetter-junior-regulatory-affairs-manager-dfm\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhellobetter-junior-regulatory-affairs-manager-dfm"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1851401}},{"tool":"search_jobs","arguments":{"company":"hellobetter.de","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1851401},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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