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