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Principal Regulatory Affairs Specialist

Shanghai, China | , China

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Location Shanghai, ShanghaiCN Job ID JR-020954

1. Preparation and timely completion of global registration submissions (CE IVDR, US FDA, Healthcare authority in APAC region, etc) for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs

2. Development of regulatory plan for global registration submission (CE IVDR, US FDA, Healthcare authority in APAC region, etc) for Taicang manufactured IVD products.

3. Create relevant documentation and provide consultancy as an expert in regulatory affairs for R&D and clinical scientific team to comply with IVDR regulation.

4. Support global Regulatory teams and/or in-country dealers/representatives with regional regulatory registrations.

5. Follow-up related EU and FDA regulation upgrades, CLSI guidance, and arrange internal discussion for new upgrades’ impaction and follow-up plan.

6. Build and maintain effective working relationships with Notify Body and regional authority.

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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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