Regulatory Affairs Specialist - Supporting China Product Registration
Core
Ensure regulatory compliance for products entering the China market by managing filings, licenses, and post-market activities.
Role type
Regulatory Affairs Specialist (China)
Builds
Regulatory submissions, product registrations, and compliance documentation for the China market.
Domain
Medical Devices / Robotic Surgery / China Market
Deliverable
client delivery
Required skills
Regulatory affairs lifecycle management, pre-market application preparation, post-market compliance reporting, regulatory intelligence analysis, project coordination, technical documentation translation, database management, procedure development
Preferred skills
International submission support, Product Technical Requirement (PTR) drafting, clinical evaluation study support, Approved Product List (APL) process management, recall coordination, RIMS system usage, SAP knowledge, Agile methodology
Technologies
Veeva, Rimsys, Microsoft Word, Excel, Project, SAP
Responsibilities
Serve as RA project point of contact for China product registrations and filings; Prepare and submit regulatory documents to Chinese authorities; Maintain regulatory clearances and approvals; Conduct global regulatory assessments (GRA); Provide regulatory guidance for new product development; Support post-market activities including PSURs and recalls; Develop departmental procedures and databases; Participate in clinical evaluation studies.
Seniority
Mid-level, hands-on IC