SSME AT (Senior) Quality Assurance & Regulatory Affair Engineer

Job Description

Quality Assurance:
1. Participate SOP establishment/maintenance for Device marketing, design and development, manufacturing with AT multiple sites, according to business requirements and international quality regulations.
2. 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.
3 . 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.
4 . Monitor manufacturing quality, initiate data analysis, support corrective and preventive actions if necessary. Exchange information with DCU, timely raised potential trend issues to CCB. 
5. Participate and handle the internal/external audits, initiate and follow-up the continuous improvements. 

Regulatory Affairs: 
1. 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.
2 . Catch global regulations and standards updates, ensure they can be implemented in related SOPs and products.
3 . Analyze the change impact to country license, notify regional units for the changes, perform license update/filing/renewal within whole product life cycle.
4 . Support oversea product transferred to local manufacturing, including design transfer,R4, NMPA license submission and R5 milestones if necessary.
5. 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.

Organization: Siemens Healthineers

Company: Siemens Shanghai Medical Equipment Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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