Regulatory Affairs Manager / Regulatory Affairs Specialist / Regulatory Project Manager (Digita[...]

Stryker Corporation; Berlin; Hybrid; EUR 55.000 - 85.000; Vollzeit

Zusammenfassung

An innovative digital health platform is seeking a Regulatory Affairs Manager to shape compliance processes for their medical software product. This role involves translating regulatory requirements into actionable tasks for developers, ensuring adherence to standards like ISO 13485, and maintaining high-quality documentation. The ideal candidate will thrive in a fast-paced environment, possess a strong understanding of Software-as-a-Medical-Device regulations, and enjoy working cross-functionally with various teams. Join a mission-driven organization that values compliance and innovation in the digital health space.

Leistungen

Flexible working hours

Remote-friendly setup

Quarterly travel to Berlin HQ

Qualifikationen

• Hands-on experience with ISO 13485 in a software environment.
• Ability to write technical tickets based on compliance requirements.

Aufgaben

• Implement regulatory frameworks like MDR and ISO 13485.
• Create and maintain high-quality documentation for compliance.
• Support audits and ensure compliance throughout the product lifecycle.

Kenntnisse

ISO 13485

Regulatory Compliance

Technical Documentation

Jira

Agile Methodologies

Ausbildung

Bachelor's Degree in Life Sciences or Engineering

Master's Degree in Regulatory Affairs

Tools

Confluence

Jobbeschreibung

Location: Berlin Hybrid or Remote (Germany-based) with regular travel to Berlin (at least every 2 months)
Languages: Fluent in English & German (C1+)

About NeuroNation

NeuroNation is one of the leading digital health platforms, helping over 30 million users around the world train their cognitive abilities and maintain independence in everyday life. Our scientifically-backed app is DiGA-listed, prescribed by doctors, and fully reimbursed by public health insurance in Germany.

We work closely with researchers, universities, and public institutions like the German Federal Ministry of Health. Our app has been recognized by Apple, Google, and major German health insurers.

Now, we're growing our regulatory team - and we're looking for someone who can ensure that our software-based medical product stays fully compliant while reaching even more people in need.

Your Role

As Regulatory Affairs Manager / Regulatory Affairs Specialist, you will be responsible for managing and implementing compliance and regulatory processes across our digital health business.

You'll work closely with our developers and project managers to translate regulatory requirements into actionable Jira tickets, and ensure these are implemented correctly and documented in line with our quality standards. You'll also support audits, manage technical documentation, and be a central figure in ensuring we remain compliant with related standards.

This is a great opportunity for someone who thrives in a fast-moving tech environment, but also brings regulatory depth and hands-on ticket writing experience in the Software-as-a-Medical-Device (SaMD) domain.

Responsibilities

• Interpret and implement regulatory frameworks (e.g., MDR, ISO 13485 for Software-as-a-Medical-Device) within the company
• Translate regulatory requirements into technical tickets for developers (e.g., in Jira)
• Create and maintain high-quality documentation: SOPs, policies, audit materials, labeling documents
• Prepare and support internal and external audits and certification processes
• Work closely with product, QA, engineering, and external partners to ensure compliance throughout the product lifecycle
• Stay up-to-date on SaMD regulations, standards, and compliance best practices
• Drive improvements in compliance awareness and implementation across the company
• Travel to Berlin is required at least every 2 months

You're a perfect fit if you:

• Have significant hands-on experience with ISO 13485 for Software-as-a-Medical-Device in a software company (not hardware only)
• Have worked on Software-as-a-Medical-Device (SaMD) and understand its regulatory challenges
• Know how to write basic technical tickets for developers, based on compliance or quality requirements
• Are comfortable working cross-functionally with developers and technical project leads
• Are fluent in German and English (C1+)
• Are detail-oriented, structured, and self-driven

Bonus points for:

• Experience with GDPR, ISO 27001, IEC 62304, or similar regulations
• Familiarity with Jira, Confluence, or other documentation/ticketing tools
• Experience working in agile product teams or tech start-ups

What we offer:

• The chance to shape the regulatory foundation of a growing medically certified digital health app
• Work with cutting-edge technology and a fast-growing, mission-driven team
• Flexible working hours (core: 9:30-16:30 CET) and remote-friendly setup
• Quarterly travel (at least every 2 months) to our Berlin HQ

Interested?

If you're passionate about compliance, digital health, and bridging the gap between regulation and implementation - we'd love to hear from you.

Apply now via our career page and help us stay ahead in digital medical compliance!