SSME AT Regulatory Affair Manager/Senior Specialist

Job Description


  • Establish/maintance the device marketing relevant SOPs with AT multiple sites, lead China specific regulation/standards update and implmenation in global surgery products.
  • Make new license submissiong plans for the new products or update or renew plans for big product changes.
  • Ensure that RA activities including supporting new product registration, product lifecycle maintenance (renewal, variations, compliance etc.)  And provide guidance on license strategy to product development.
  • To ensure the development and strengthening of relationships with  competent authorities, agents, internal departments, as required, to ensure appropriate input into regulatory strategy and gain rapid approval of submissions, and ensure license acquired timely.
  • Catch global regulations and standards updates, and ensure they can be implemented in device marketing SOPs and relevant products.
  • Support on transfer product, which is designed by SHS oversea company and transferred to SSME, including design transfer, R4,  NMPA license submission and  R5, when necessary.
  • As the China regulation main contributor to SSME cross function RA team.
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  • Requirement:
  • More than 8 years experiences in international healthcare, for both Medical device license submission and project/product development quality control.
  • Be familiar with China and international regulations on medical devices in registration and development.
  • Good in written and spoken English and Mandarin
  • Education:

·         Bachelor degree above, major in medical device relevant area, project management and/or advance degree is preferred.

Organization: Siemens Healthineers

Company: Siemens Shanghai Medical Equipment Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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