Regulatory Affairs Specialist

iO Associates; Berlin; Remote; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading digital health platform is seeking a Regulatory Affairs Specialist in Berlin. This pivotal role involves overseeing compliance and regulatory processes, translating requirements into actionable items, and collaborating with product teams. Candidates should possess hands-on experience with relevant ISO standards and be fluent in both German and English.

Leistungen

Remote friendly set-up

Travel and accommodation covered for periodic visits

Qualifikationen

• Experience with ISO 13485 for Software-as-a-Medical-Device.
• Understanding of regulatory challenges for Software-as-a-Medical-Device.
• Ability to write technical tickets based on compliance requirements.

Aufgaben

• Oversee compliance and regulatory processes within digital health.
• Collaborate with developers and project managers to translate regulatory requirements.
• Support audits and manage technical documentation.

Kenntnisse

Regulatory Compliance

Technical Documentation

Fluency in German

Fluency in English

ISO Standards Knowledge

Tools

Jira

Confluence

Jobbeschreibung

Regulatory Affairs Specialist | Digital Health | Berlin (Remote)

iO Associates are partnering with a leading digital health platform, in their search for a Regulatory Affairs Specialist. This is a newly created role due to good company growth where you will be overseeing compliance and regulatory processes within their digital health business.

Being part of the Product team, you will be collaborating with developers and project managers and translating regulatory requirements into actionable Jira tickets. Your responsibilities include supporting audits, managing technical documentation, and ensuring compliance with related standards, making you a pivotal figure in the business's regulatory efforts.

Experience required :

• Hands-on experience with ISO 13485 for Software-as-a-Medical-Device in a software company.
• Have worked on Software-as-a-Medical-Device (SaMD) and understand its regulatory challenges.
• Can write technical tickets for developers based on compliance or quality requirements.
• Are fluent in German and English (C1+)
• Experience with GDPR, ISO 27001, IEC 62304, or similar regulations.
• Familiarity with Jira, Confluence, or other documentation / ticketing tools

This is an exciting time to join a growing medically certified digital health app business - you will be able to shape the regulatory foundation, work with cutting-edge technology and a fast-growing, mission-driven team. So, if you're passionate about compliance, digital health, and bridging the gap between regulation and implementation, please apply now!

Please note that you will be required to travel to Berlin every two months - travel and accommodation will be paid by the company, and they do provide a remote friendly set-up. And you must have the right to work in Germany - sponsorship is not provided.