德国律维施泰因医学技术有限公司招聘——Regulatory Affairs Specialist

Goals/Mission

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.

Working Partners/Contacts

- 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

Qualifications

Education

Bachelor degree in Medical Science/Engineering/Marketing

CET 6 or higher

Experience

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.

Capabilities

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


工作地点:延安西路1538号怡德大厦B座1楼


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