Regulatory Affairs Manager

Signify Technology; Köln; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

An innovative digital health company is seeking a Regulatory Compliance Specialist to bridge regulatory requirements with practical implementation. This role involves translating complex regulations into actionable Jira tickets while ensuring compliance with quality standards. Ideal candidates will have solid experience in Software-as-a-Medical-Device (SaMD) and a strong grasp of ISO 13485. Join a dynamic team dedicated to enhancing the cognitive abilities of over 30 million users globally, and make a significant impact in the field of digital health.

Qualifikationen

• Experience applying ISO 13485 in a software-focused medical device company.
• Direct involvement with Software-as-a-Medical-Device (SaMD).

Aufgaben

• Interpret and apply regulatory frameworks such as MDR and ISO 13485.
• Translate compliance requirements into actionable developer tickets.
• Create and maintain high-quality regulatory documentation.

Kenntnisse

Regulatory Knowledge

ISO 13485

German Language (C1 Level)

Software-as-a-Medical-Device (SaMD)

GDPR Compliance

Tools

Jira

Confluence

Jobbeschreibung

We are helping a leading digital health company that is empowering over 30 million users worldwide to enhance their cognitive abilities and maintain independence in daily life.

Your Role :

In this role, you’ll serve as the bridge between regulatory requirements and practical implementation. Working closely with developers and project managers, you will translate complex regulations into clear, actionable Jira tickets and ensure they are executed and documented in compliance with our quality standards.

This is an ideal opportunity for someone who thrives in a dynamic tech environment while bringing strong regulatory knowledge and hands-on experience in Software-as-a-Medical-Device (SaMD).

What You’ll Do

• Interpret and apply regulatory frameworks such as MDR and ISO 13485 within a SaMD context
• Translate compliance requirements into actionable developer tickets (e.g., using Jira)
• Create and maintain high-quality regulatory documentation, including SOPs, policies, audit materials, and labeling
• Collaborate with cross-functional teams : product, QA, engineering, and external partners
• Stay current on evolving SaMD regulations and standards
• Drive awareness and implementation of compliance practices across the organization
• Travel to Berlin at least once every two months

What We’re Looking For

• Solid experience applying ISO 13485 in a software-focused (not just hardware) medical device company
• German speaking ( C1 level )
• Direct involvement with Software-as-a-Medical-Device (SaMD)
• Ability to write basic technical tickets derived from quality and regulatory requirements
• Familiarity with GDPR, ISO 27001, IEC 62304
• Experience using tools like Jira, Confluence, or similar documentation system