| 职 位 描 述： |
职位描述:
- Assist in the preparation of applications for registration of new products, 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 therapeutic goods
- 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 Dept
- Maintain contact with officials of the CFDA, and industry associations through attendance at meetings, conferences and seminars as appropriate
岗位要求：
- 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
- Can 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 |
