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SSMR MR 法规注册专员 RA Specialist

Job Description

Mission and responsibilities:
1. Ensure the implementation of requirements of regulatory and standards by assigning and reviewing design input, testing and assessment of conformity
2. Coordinate 3rd party to perform type test for country approvals.
3. Support the business by consult super conduct magnet's design, manufacture, supplier selecting and development in compliance with global pressure equipment regulations.
4. Maintenance of the license for super conduct magnet manufacturing.
5. Has the authority and is obliged to stop any processes and projects in cases where the regulatory requirements is not fulfilled.
6. Regular direct reporting to RA manager.
7. Supporting contacts to RA colleagues and project manager.
8. Communicate with the audited departments to ensure the audit is performed efficiently and the non-compliance findings are followed

Your qualifications and experiences:
1. Perfect technical writer
2. Good public relations
3. Medical device product knowledge
4. Benchmarking, audits, reviews, assessments
5. Train-the -trainer
6. Fluent English
7. Quality assurance know -how, product safety and risk management
8. Procedure & standards understanding (ISO9001, ISO13485, QSR, etc.)

Organization: Siemens Healthineers

Company: Siemens Shenzhen Magnetic Resonance Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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