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Regulatory Specialist
Job in
South Portland, Cumberland County, Maine, 04106, USA
Listed on 2026-02-01
Listing for:
ProKatchers LLC
Full Time
position Listed on 2026-02-01
Job specializations:
-
Healthcare
Healthcare Compliance, Medical Science Liaison
Job Description & How to Apply Below
- 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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