Actalent
South Portland, ME, USA
Actalent is hiring a Regulator Specialist for a global healthcare group in the South Portland area!!! SUMMARY The position of Regulatory Affairs Specialist II is within Infectious Disease business unit. In this role you will prepare documentation for EU Technical Files and international product registrations. RESPONSIBILITIES: 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...


