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.