Junior Regulatory Affairs Manager

🔥 17 hours ago

🇩🇪 Germany – Remote

💵 €49k - €57k / year

⏰ Full Time

🟢 Junior

🚔 Compliance

👻 Ghost score 0%

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HelloBetter

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

🏥 Healthcare

🧘 Wellness

⚕️ Healthcare Insurance

Healthcare • Wellness • Healthcare Insurance

HelloBetter is an online platform that offers psychological therapy courses that can be accessed via prescription. It provides scientifically-proven online therapy courses for a variety of mental health issues such as stress, burnout, sleeping disorders, panic attacks, chronic pain, vaginismus, and the emotional burdens associated with diabetes. The courses are designed to be completed over several weeks and include psychological guidance and feedback. HelloBetter aims to improve psychological support accessibility, allowing users to receive help free of charge through health insurance. The platform has been recognized for its extensive research with numerous controlled studies supporting the efficacy of its programs.

📋 Description

• Own ongoing conformity of HelloBetter's Class I software as a medical device under MDR (Regulation (EU) 2017/745) and MPDG • Maintain and evolve the Integrated Management System and Technical Documentation • Maintain and improve the ISO 13485 quality management system and alignment with EN 62304, ISO 14971, and EN 62366 • Run post-market surveillance and post-market clinical follow-up end to end • Monitor incidents, drive CAPAs to closure, and handle reporting obligations to competent authorities when required • Lead internal and external ISO 13485 audits and participate in ISO 217001 audits • Close audit findings and maintain audit-ready documentation • Track regulatory developments including the AI Act, DiGAV amendments, and updated BSI guidelines • Translate regulatory changes into actionable guidance for product, engineering, and clinical teams • Support Research with §139e SGB V / DiGAV fast-track applications • Drive preliminary-to-permanent DiGA listing conversions • Act as secondary point of contact for BfArM • Use AI tools to accelerate technical documentation, audit preparation, and regulatory processes such as Supplier Management • Improve the speed, efficiency, and effectiveness of the Regulatory Affairs setup

🎯 Requirements

• Completed degree in a relevant field such as life sciences, engineering, law, health sciences, or similar • 2+ years of hands-on working experience with MDR, ISO 13485, or DiGAV, applied to a device • Fluent English, written and spoken • German is a strong plus • Comfortable working in agile development environments • Ability to translate regulations into actionable one-page plans • Practical fluency with AI tools for regulatory and QMS work • Track record of owning an audit or certification process from preparation through closure • Strong project management, analytical, interpretive, communication, and problem-solving skills • Nice to have: digital health startup experience • Nice to have: SaMD/DiGA-specific submission experience, including §139e SGB V fast-track • Nice to have: familiarity with EN 62304, ISO 14971, EN 62366, ISO 27001, or BSI TR-03161 • Nice to have: experience building or improving a QMS

🏖️ Benefits

• VSOP (one-time, 5% of yearly salary for Junior IC L1; 10% of yearly salary for Mid-level IC L2) • Remote-first culture with global hiring within a +/- 4.5 hours CET time window • Use of offices in Berlin and Hamburg if preferred • Relocation option and support • Flexible working hours • 28 vacation days plus 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 • Additional 10 paid leave days for non-birth parents after the birth or adoption of a child • Personal growth and employee development support • Inclusive, equal-opportunity workplace and Anti-Harassment Policy