RA Specialist

3 weeks ago

Beijing, Beijing, China Straumann Full time

RA Specialist

Main Purpose of the Role

The RA Specialist will be responsible for the routine regulatory affairs and quality assurance of alloted products.

Key Responsibilities

  • Take charge of all routine registration activities including testing, file preparation, submission, tracking registration process and achieve license target in fast and effective way.
  • Assess regulatory impacts on various product changes.
  • Monitor NMPA's relevant registration regulations, policy and related standards. Ensure product comply to the requirements and standards.
  • Maitain or develop good working relationship and cooperation with authorities (CMDE, Testing lab,etc.) to improve working efficiency.
  • Ensure Zero finance impact caused by improper regulatory strategy in registration submission.
  • Coordinate with cross functional team to ensure product registration approval on time, and also other regulatory related actives.
  • Provide regulatory support on pre-market and post market cases on responsible product branding.
  • Perform other duties as needed.

Skills and Competencies

Education / Professional Experience

  • Bchelor's Degree or above, Medical device related major
  • 5+ years of relevant working experience in Medical device registration, especially passive medical device in MNC.
  • Good verbal and written skills in English

Personal Competencies

  • Fast learning capability
  • Good cooperation skill to work with cross-function team
  • Active attitude to responsible

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