Staff Regulatory Affairs

Develop global regulatory strategies for registration of IVD reagents and systems.

Maintain regulatory documentation, declarations, certificates, and submission archives.

Handle US submissions (510(k)s, Q-Subs), EU Technical Documentation (IVDR), and ROW submissions (technical dossiers or STED).

Support internal and external audits by Notified Bodies or regulatory authorities.

Collaborate with cross-functional teams for New Product Development and regulatory project execution.

Manage product lifecycle compliance, including design changes, labeling updates, and regulatory impact assessments.

Apply Danaher Business System (DBS) tools to improve regulatory processes and ensure compliance.

Represent Regulatory Affairs in core project teams, design reviews, and risk management reviews.