Regulatory Affairs Manager Remote (copy)
Quidel
Remote
regulatory
manager
remote
regulatory
patients
ortho
clinical diagnostics
remote
manager
team
mission
manufacturer
product portfolio
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December 21, 2022
Quidel
Chicago, IL
FULL_TIME
Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. We are a leading manufacturer of point of care diagnostic solutions. Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.
We are excited to announce that Quidel Corporation is now becoming QuidelOrtho! This transaction will bring together two world-class teams and complementary product portfolios to serve patients around the world. During this transition period, we encourage you to continue visiting our career site and also check out more career opportunities at Careers at Ortho Clinical Diagnostics | Ortho Clinical Diagnostics jobs Join our journey as we become one global diagnostics leader!
We are looking for a remote Regulatory Affairs Manager to join our Regulatory Affairs team. The Regulatory Affairs Manager implements regulatory activities related to the approval of new IVDs (in vitro diagnostics) and medical devices into the worldwide market, as directed. Participates on product development teams and provides guidance and strategies for regulatory issues. Interacts with regulatory agencies regarding product registrations, licensures and permits, and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVDD/IVDR, CFR and other worldwide regulatory requirements. Reviews and approves labeling and Marketing/Sales literature.
This position operates from roughly 8:00 am - 5:00 pm Pacific Standard Time, Monday - Friday.
#LI-AP1
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Before you apply, please make sure you share Quidel’ s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer driven, focused on execution, and new product oriented. We succeed by being determined, optimistic team players.
Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
We are excited to announce that Quidel Corporation is now becoming QuidelOrtho! This transaction will bring together two world-class teams and complementary product portfolios to serve patients around the world. During this transition period, we encourage you to continue visiting our career site and also check out more career opportunities at Careers at Ortho Clinical Diagnostics | Ortho Clinical Diagnostics jobs Join our journey as we become one global diagnostics leader!
We are looking for a remote Regulatory Affairs Manager to join our Regulatory Affairs team. The Regulatory Affairs Manager implements regulatory activities related to the approval of new IVDs (in vitro diagnostics) and medical devices into the worldwide market, as directed. Participates on product development teams and provides guidance and strategies for regulatory issues. Interacts with regulatory agencies regarding product registrations, licensures and permits, and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVDD/IVDR, CFR and other worldwide regulatory requirements. Reviews and approves labeling and Marketing/Sales literature.
This position operates from roughly 8:00 am - 5:00 pm Pacific Standard Time, Monday - Friday.
#LI-AP1
#LI-Remote
Before you apply, please make sure you share Quidel’ s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer driven, focused on execution, and new product oriented. We succeed by being determined, optimistic team players.
Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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