Staff Regulatory Affairs

Develop and execute complex strategies for global registration of IVD reagents and systems, including US, EU, and ROW submissions.

Maintain regulatory documentation, declarations, certificates, and submission archives to ensure compliance with applicable standards.

Support new product development by collaborating with cross-functional teams, contributing to project plans, timelines, and regulatory submissions.

Manage product lifecycle regulatory requirements, including design changes, labeling updates, and sustainment activities.

Ensure compliance with internal SOPs, global regulatory standards, and quality systems such as FDA QSR, IVDR, ISO 13485, and ISO 9001.

Apply Danaher Business System (DBS) tools to improve processes, prevent business interruptions, and enhance regulatory capability.