To assist Chief RepresentativeANDadminister regulatory affairs by coordinating with the Chinese authority and external partners onMedical Deviceregistration.
To monitor the regulation updates and new registration cases in industry that LM Group involved.
To prepare the annual cost budget for RA function.
- Internal: International Registration Affairs team,Product Management, R&D, Technical Support of HQ, Product manager, Technical Support, Customer Service of LMT China.
- External: CFDA, CMDE, CQC, 3rd party test bodies (LMTI, BIMT, CMTC), local authority, Registration Agents.
Function & Responsibilities
Assist in the preparation of application for registration of newproducts, variations to marketed products, where required
Assist with responses to deficiency letters and other requests for data from regulatory agencies
Assist in the preparation and monitoring of technical tests in local CMTC labs
Review and prepare applications for Renewal Products
Maintain and update the database of all registration certificates available in the industry in a monthly base
Cost and time analysis for each new and renewal project
Maintain an up to date knowledge of the relevant legislation in China relating to diagnostic and therapeutic products
Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products
Provide regulatory advice to company personnel as required
Maintain regulatory documentation in line with International Registration Service
Maintain contact with officials of the CFDA, and industry associations through attendance at meetings, conferences and seminars as appropriate
Bachelor degree in Medical Science/Engineering/Marketing
CET 6 or higher
At least 2 years’ Medical Devices (Active, CLASS III) registration experience.
Experience in CCC, ROHS mark application or local Medical Devices registration is a plus.
Willing to work successfully under pressure and in a time constrained environment
Proactive, good planning and learning ability, good communication skills and teamwork.
Proficiency in Basic Microsoft Word, PowerPoint and Excel
Ability to integrate data, summarize and communicate at point of service
Professional business ethics