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SSME AT QT Quality Assurance & Regulatory Affair Engineer

Job Description

Take both Quality Assurance and Regulatory affair roles within whole product life cycle.

  • Quality Assurance:
  • stablishment/maintenance for Device marketing, design and development, manufacturing with AT multiple sites, according to business requirements and international quality regulations.
  • 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.
  • Supervise the change control process is properly followed within design or manufacturing process change, responsible for the change plan approval, document review, 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.
  • Participate and handle the internal/external audits, initiate and follow-up the continuous improvements.

  Regulatory Affairs:

  • 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.
  • Catch global regulations and standards updates, ensure they can be implemented in related SOPs and products.
  • Analyze the change impact to country license, notify regional units for the changes, perform license update/filing/renewal within whole product life cycle.

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.

Dimension of Function/Volume:

Drive the premarket approval relevant activities compliance with latest local countries regulations and standards.  And worked as independent quality function to review or approve development, manufacturing documents, ensure these activities are compliance to quality regulations/SOPs.

 Contacts
(internal/external):

Internal:  Cooperation with project/product team to prepare license submission/update/filing documents.  Support and consult for project/product quality control topics, join the main reviews for the decisions of milestones.  

External: collaborate with competent authorities, external agencies, SHS AT QT RA, local country RA to align the license strategy/get the license approval. And keep contacts with relevant functions of business units of SHS on process, project cooperation.

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 experience for medical devices project/product development quality control and external audits

•    Experience in R&D project quality management is a plus.

•    Good relationship with NMPA, Global license registration experience is preferred.

•    Good experience for medical devices testing and technological requirement is preferred

•    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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