Regulatory Specialist

ONWARD Medical • Lausanne, Switzerland • 1m ago

About the job

The Regulatory specialist collaborates closely with the Development, Quality and Clinical teams for the preparation and submission of Regulatory Technical documentation (with focus on EU and US authorities).

Responsibilities

Hands-on support with the Development, Quality and Clinical teams to prepare technical documentation in compliance with country specific regulations (EU and US).
Maintain and update technical files to support submissions for market approval and clinical trials (EU and FDA).
Maintain applicable standards list and traceability between technical documents and applicable standards.
Manage Packaging and Labeling requirements.
Perform routine regulatory monitoring, and coordinate with Subject matter experts the impact analysis of new/updated standards
Perform regulatory impact analysis on design change requests.