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