Senior Officer, Regulatory Affairs
About this role
Job title: Senior Officer, Regulatory Affairs
About the Role In this role you will act as the lead for regulatory affairs on cross-functional teams and own product line submissions, registrations and QMS audits in China NMPA for the Dental Solutions business. You will collaborate with the international regulatory affairs group to ensure registrations align with the business strategy and support labeling and registration changes related to the company spin-off.
What You'll Do
- Leading & conducting NPI project registrations for imported and localized medical devices
- Conducting regulatory change assessments and coordinating associated activities
- Providing regulatory review of technical reports, BER, CER and related documents
- Contributing to development and implementation of regulatory processes; documenting and managing metrics
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