Specialist, Commercial Quality & Regulatory Affairs
Core
Interpret country regulations for Danaher Dx products, devise compliance strategies, and secure market clearance/approvals for medical devices and IVDs in Taiwan and Hong Kong.
Role type
Specialist, Commercial Quality & Regulatory Affairs
Builds
Regulatory submissions, filings, renewals, post-approval changes, and QMS execution for commercial diagnostic products
Domain
Life sciences, diagnostics, biotechnology, medical devices, IVD
Required skills
Regulatory affairs principles, ISO13485 Quality Systems, technical writing, project management, cross-functional collaboration
Preferred skills
None stated
Technologies
None stated
Responsibilities
Support regulatory submissions, filings, renewals, and post-approval changes; Support health authority interactions, audits, and inspections; Analyze quality or regulatory issues and recommend actions; Maintain regulatory files and track obligations; Support investigations, deviations, complaints, and corrective actions
Seniority
Specialist, individual contributor