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