Principal Regulatory Affairs Specialist
Shanghai, China | , China
ResponsibilitiesLocation 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.
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.
Featured JobsView All of Our Available Opportunities
Recently Viewed Jobs
Meet Our People »and learn more about Rachel
"There is nothing cookie-cutter about my job. I’m never stuck doing routine tasks."
Meet Our People »and learn more about Manny
"There’s never a day I don’t think about how my team truly helps accelerate scientific research."
Meet Our People »and learn more about Lee
"Being innovative in my job is second nature. I’m constantly discovering ways to make methods easier and higher performing for the industry."
Meet Our People »and learn more about Samantha
"When I go to one of my mentors and let them know that I have learned something new, I am able to apply it in a real project right away which has been extremely helpful to my professional growth and has enabled me to continue achieving my goals."