Sr. RA Engineer
Core
Ensures Thermo Fisher China manufactured medical device products comply with China and overseas regulatory requirements.
Role type
Senior Regulatory Affairs Engineer (Medical Devices)
Builds
Regulatory documentation, product registrations, and compliance strategies for global markets
Domain
Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
cGMP/China GMP knowledge, NMPA experience, ISO9001/13485/QSR820 implementation, regulatory document preparation, post-market surveillance monitoring, adverse event reporting, impact evaluation for product changes
Preferred skills
Multicultural environment adaptability, self-motivation
Technologies
NMPA, FDA, AQSIQ, UL, CSA, CE, NSF, ISO9001, ISO13485, QSR820
Responsibilities
Prepare and control regulatory documents for China and foreign government regulations; Support authority and certified body on-site inspections; Monitor proposed post market surveillance regulatory changes and evaluate impact; Evaluate impact of complaints, non-conformances, or product changes to recommend recalls or field actions; Work with quality team to monitor adverse events and prepare reports for authorities; Implement and verify quality policies and Regulatory Affairs procedures