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Regulatory Affairs Manager / Specialist - Remote

Posted 15 weeks ago
All others
Full Time
Germany

Overview

The Regulatory Affairs Manager / Specialist will manage compliance and regulatory processes for a digital health platform, ensuring the software-based medical product remains compliant while collaborating with developers and project managers.

In Short

  • Manage and implement compliance processes in digital health.
  • Translate regulatory requirements into actionable tickets.
  • Ensure documentation aligns with quality standards.
  • Support audits and manage technical documentation.
  • Work cross-functionally with product, QA, and engineering teams.
  • Stay updated on SaMD regulations and compliance best practices.
  • Travel to Berlin at least every 2 months.
  • Hands-on experience with ISO 13485 or ISO 27001 preferred.
  • Fluent in English and German (C1+).
  • Detail-oriented and self-driven.

Requirements

  • Significant experience with regulatory frameworks.
  • Direct experience in implementing and improving QMS.
  • Ability to write technical tickets based on compliance requirements.
  • Comfortable working with technical project leads.
  • Fluency in English and German.
  • Detail-oriented and structured approach.

Benefits

  • Opportunity to shape regulatory foundation of a digital health app.
  • Work with cutting-edge technology.
  • Flexible working hours.
  • Remote-friendly setup.
  • Quarterly travel to Berlin HQ.
NeuroNation logo

NeuroNation

NeuroNation is a leading platform for cognitive health with over 30 million users worldwide. Based in Berlin, the company is dedicated to enhancing mental fitness through scientifically-backed digital programs, whether for prevention or as medical support via prescription apps. As pioneers in the 'Digital Health' sector, NeuroNation MED is the first digital health application to be reimbursed by all statutory health insurance providers. The company values empathy, structure, and a genuine desire to help others, making it an ideal workplace for those looking to make a meaningful impact while developing personally and professionally.

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