Junior Regulatory Affairs Manager

This is a fully remote position, open to applicants in Germany.

📋 Description

• Oversee the ongoing compliance of HelloBetter's Class I software as a medical device under MDR (Regulation (EU) 2017/745) and MPDG.

• Develop and enhance the Integrated Management System and Technical Documentation.

• Maintain and advance the ISO 13485 quality management system, ensuring alignment with EN 62304, ISO 14971, and EN 62366.

• Execute post-market surveillance and post-market clinical follow-up from start to finish.

• Monitor incidents, drive CAPAs to resolution, and manage reporting obligations to relevant authorities when necessary.

• Lead both internal and external ISO 13485 audits and engage in ISO 217001 audits.

• Address audit findings and keep audit-ready documentation up to date.

• Keep track of regulatory developments, including the AI Act, DiGAV amendments, and revised BSI guidelines.

• Convert regulatory changes into actionable guidance for product, engineering, and clinical teams.

• Assist Research with §139e SGB V / DiGAV fast-track applications.

• Facilitate the transition from preliminary to permanent DiGA listings.

• Act as a secondary contact for BfArM.

• Utilize AI tools to streamline technical documentation, audit preparation, and regulatory processes such as Supplier Management.

• Enhance the speed, efficiency, and effectiveness of the Regulatory Affairs framework.

⛳️ Requirements

• Bachelor's degree in a relevant discipline such as life sciences, engineering, law, health sciences, or a related field.

• Minimum of 2 years of practical experience with MDR, ISO 13485, or DiGAV as applied to a device.

• Proficiency in English, both written and spoken.

• Proficiency in German is a significant advantage.

• Comfortable in agile development environments.

• Ability to interpret regulations and create actionable one-page plans.

• Practical familiarity with AI tools for regulatory and QMS tasks.

• Proven experience in managing an audit or certification process from preparation to completion.

• Strong project management, analytical, interpretive, communication, and problem-solving abilities.

• Preferred: experience in a digital health startup.

• Preferred: experience with SaMD/DiGA-specific submissions, including §139e SGB V fast-track applications.

• Preferred: knowledge of EN 62304, ISO 14971, EN 62366, ISO 27001, or BSI TR-03161.

• Preferred: experience in developing or enhancing 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 recruitment within a +/- 4.5 hours CET time zone.

• Access to offices in Berlin and Hamburg if desired.

• Relocation options and support available.

• Flexible working hours.

• 28 vacation days plus compensation for public holidays that fall on weekends.

• Tenure-based paid time off, offering up to three additional days.

• Permanent employment contract.

• Attractive VSOP (Virtual Stock Option Plan) available for all employees.

• Tax-deductible pension plan with a generous employer contribution.

• Free or subsidized gym memberships.

• Regular team-building events.

• Additional 10 paid leave days for non-birth parents following the birth or adoption of a child.

• Support for personal growth and employee development.

• An inclusive, equal-opportunity workplace along with an Anti-Harassment Policy.