Information Security Manager / Quality Manager / Regulatory Affairs Manager (Digital Health)
Join to apply for the Information Security Manager / Quality Manager / Regulatory Affairs Manager (Digital Health) role at NeuroNation - Mind & Brain Health Technology
Information Security Manager / Quality Manager / Regulatory Affairs Manager (Digital Health)
Join to apply for the Information Security Manager / Quality Manager / Regulatory Affairs Manager (Digital Health) role at NeuroNation - Mind & Brain Health Technology
NeuroNation is one of Europe’s leading digital health platforms, empowering over 30 million users to train their cognitive abilities and maintain independence in daily life.
Our scientifically validated app — NeuroNation MED — is listed as a DiGA (digitale Gesundheitsanwendung) by the German Federal Institute for Drugs and Medical Devices (BfArM). It can be prescribed by physicians, and its cost is fully covered by public health insurers.
We collaborate with leading research institutions, health insurers, and government bodies including the German Federal Ministry of Health. Our work has been recognized by Apple, Google, and major insurers like AOK.
To strengthen our internal structures, we’re looking for someone with proven hands-on experience in quality management or information security management for software products—to help us maintain and scale compliance with leading standards like ISO 13485 or ISO 27001.
As our Information Security Manager / Quality Manager / Regulatory Affairs Manager, you’ll take ownership of critical processes that ensure our product and organization remain compliant with international standards in the digital health space.
You’ll act as the bridge between regulatory frameworks and our product/development teams, translating compliance requirements into understandable, actionable tasks. Your work will help us scale our medical and security infrastructure, prepare for audits, and continuously evolve our quality system in line with regulatory expectations.
This role is perfect for someone who enjoys working in a fast-paced, digital-first environment and has previously led or significantly contributed to certification processes under ISO 27001 or ISO 13485 in software companies.
* Ensure compliance with ISO 27001 and ISO 13485 (for SaMD), including maintaining documentation and driving audit readiness
* Translate compliance requirements into clear tasks and Jira tickets for cross-functional teams
* Build and optimize our internal Quality Management System (QMS) or Information Security Management System (ISMS), including SOPs, policies, risk logs, and traceability matrices
* Collaborate with product, development, QA, and external consultants to ensure compliant implementation
* Lead internal or external audit preparation and support certification processes
* Improve awareness of compliance topics across teams and support continuous learning
You're a great fit if you:
* Have hands-on experience with ISO 13485 or ISO 27001 in a software company (not just hardware or Pharma)
* Have directly contributed to implementing, maintaining, or improving a QMS or ISMS — not only assisting others
* Can travel to Berlin HQ at least every 2 months for on-site collaboration
* Can confidently assess your experience level as advanced, not basic
* Are able to write compliance-related tickets or documentation that developers and product managers can act on
* Are comfortable working cross-functionally and independently
* Are fluent in German and English (C1+)
* Experience with GDPR, MDR, IEC 62304, or software-specific regulatory frameworks
* Background in agile environments or tech startups
* Familiarity with Jira, Confluence, or QMS tools
* A meaningful mission: Improve cognitive health with a product used daily by thousands of people
* Work with a collaborative, mission-driven team in a growing medically certified digital health company
* Flexible working hours (core: 9:30–16:30 CET)
* Remote-first setup with regular team meetups in Berlin
* A high-impact role with autonomy and visibility across the organization
Ready to Apply?
If you’re passionate about compliance, quality, and software — and want to be part of a purpose-driven health tech company — we’d love to hear from you.
Apply now via our career page and help shape the future of brain health at NeuroNation.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Information Technology
* Industries
Health and Human Services
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