Sr Manager, Regulatory Affairs

1 month ago

Beijing, China Thermo Fisher Scientific Full time

Job Description

Main Tasks & Responsibilities

  • Develop and implement competitive registration strategy for medical and life science products such as medical device, IVD, animal health/human identification products, etc.
  • Make sure the registration activities and submissions are done in an accurate, timely and cost-efficient manner.
  • Closely liaise with regulatory authorities including but not limited to NMPA, PMPA, Ministry of Public Security and Ministry of Agriculture, to optimize the advancement of product registration activities.
  • Establish and maintain cross-function communications to make project team fully aware the regulatory requirements and the supports needed; efficiently solve issues to achieve project goals.
  • Work with 3rd party partners with direct negotiations and liaisons, provide regulatory inputs for partnership/OEM/license in/license out when necessary.
  • Monitor regulatory environment changes, proactively and accurately assess and interpret regulatory requirements and impacts.
  • Manage and develop team members to support the growing business team.
  • Support labeling and quality projects; handle other tasks assigned by line manager.

Qualification

  • Bachelorâs degree or above, major in medicine/biology/bio engineering/pharmaceuticals or related fields
  • Excellent knowledge and competency in medical device/IVD registration, traceable experience in successful registration projects in both imported and domestic Class II/III devices after 2014 is preferable.
  • 10+ years of experiences in medical device/IVD industry, with more than 5 years in management role
  • Experience in leading successful team and projects. Excellent skills in multi-task management, problem solving and creative thinking.
  • Able to work under pressure.
  • Excellent written and verbal communication skills in both Chinese and English. Advanced computer skills in Office software

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