Sr. RA Engineer

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Position Summary

primarily responsible for Thermo Fisher China manufactured product compliance to both China and oversea regulatory requirements.

Key Responsibilities

Prepares and controls of regulatory documents in compliance with applicable China and foreign government regulations
Support authority and certified body on-site inspection, such as NMPA, FDA, AQSIQ, UL, CSA, CE, NSF etc
Regulations and relevant standards collection, updating and informing
Performs product registration/licensing activities including preparation and control of documents
Monitor proposed post market surveillance regulatory changes, evaluate impact, and escalation
Evaluate the impact if any complaint, non-conformance, product changes or other deviations for regulated products and recommend if any recall, MDR, field action is required
Work with quality team to monitor adverse event and prepare report of adverse event for regulatory authorities
Preparation, implementation, conformance and verification of quality policies and Regulatory Affairs procedures

Minimum Requirements/Qualifications

Understand cGMP/China GMP requirements
Has solid knowledge of relevant regulatory requirements
Above 5 years RA experiences in medical devices industry
Working experience with NMPA
Implementation experience in ISO9001&13485 & QSR820
Excellent oral and written communication skill in English, be able to work in a multicultural environment
Strong willing to learn, and self-motivated
Strong inter-personal skills