Regulatory Specialist

Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally. Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments. Researches and communicates scientific and regulatory information in order to write submission documents. Compiles and publishes all material required for submissions, license renewals, and annual registrations. Maintains approvals/licenses/authorizations for existing marketing authorizations. Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.

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