上海招聘

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

德国万曼医疗器械有限公司历史追溯至1874年，最初坐落于德国Ludwigshafen。公司致力于在通气治疗、睡眠诊断和睡眠治疗等重要医疗领域为医生与患者提供最高品质的医疗设备与系统解决方案。

万曼产品卓越的品质源于130多年的宝贵经验、充满激情的员工以及我们对自己产品的深刻理解。我们心中始终牢记患者和医生的利益，为他们研发经济实用、贴近需求、治疗范围更广的医疗产品和系统解决方案。

Founded in 1874 as a precision mechanics company in Ludwigshafen, Weinmann Gerte für Medizin GmbH + Co. KG develop, produce and market diagnostic and therapeutic system solutions of the highest quality.

partner for life – We promise reliability and the best possible quality. Our pledge is backed by more than 130 years of experience, highly motivated staff members and our close contact with customers and users. We create innovative, economical and customized products for valid diagnoses and a broad therapy spectrum for the benefit of patient, doctor and cost carrier.