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(Senior) Quality Assurance & Regulatory Affair Specialist/ Quality Assurance & Regulatory Affair manager

Job Description

  • stablishment/maintenance for Device marketing, design and development, manufacturing with AT multiple sites, according to business requirements and international quality regulations.
  • Catch global regulations and standards updates, ensure they can be implemented in related SOPs and products.
  • Ensure that product engineering process (PEP) is strictly followed by project team and all quality requirements are fulfilled.  Work closely with project team and provide process supports to project/product team, participate in the review and evaluation on relevant documentation coming from different milestones of project/product development.
  • Provide guidance on license strategy to product development, make product registration plans for new developed products/significant changes, and perform the registration as per plan.
  • Supervise the change control process is properly followed within design or manufacturing process change, resposonsible for the change plan approval, document review, change notification to regional units, license update/filing, and final release the changes within whole product life cycle.
  • Monitor manufacturing quality, initiate data analysis, support corrective and preventive actions if necessary. Exchange information with DCU, timely raised potential trend issues to CCB.
  • Develop and strengthen the 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.
   ·        Participate and handle the internal/external audits, initiate and follow-up the continuous                                   improvements.


Experience:

•    More than 7 years experiences in international healthcare, for both project/product development quality assurance and license registration.

•     Be familiar with China and international regulations on medical devices in registration and development.

  • Good in written and spoken English and Mandarin.

Organization: Siemens Healthineers

Company: Siemens Shanghai Medical Equipment Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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