苏州招聘

职位描述：
Responsibilities:
Response to gather all medical regulation and for new project transferring
Response for the production re-registration and manufacture license revise periodically
Participation as Regulatory Affairs Part in local R&D projects
Ensure that regulatory authorities’ requirements are met for products engineered and manufactured
Along with project engineer, ensures that each product complies with local, regional, and/or national registration, safety, and other required approvals before product are delivered to the customer
Evaluation and implementation of Design Change Requirement/Design Change Order(DCR/DCO) on products produced in China
Make short term and long term plan on product registration and product innovation
Post market support: to keep the compliance to the regulatory in different market
Monitor the Medical device regulatory in different main market, and keep effectiveness of regulatory in local site and to the products.

Requirement:
Bachelor degree
More than 5 years RA experience in Medical device or Pharmaceutical industry
Experience including international Regulatory Affairs is a plus
Familiar with ISO 13485 and 9001 standards and FDA 21 CFR 820
Good problem solving skills
Team player and stable personality
Mature and independent
Responsible and take accountability
Fluent in English 举报 分享

Sphere established in 1998 years.
Up to now, Sphere have a successful track recorder to our client which include 500 fortune company, successful position include senior management, technical engineering, research and development, marketing and sales etc.
Sphere won support and trust from our client depend on our high working effect.