Senior Regulatory Affairs Associate

Ortho Clinical Diagnostics(3 months ago)

Pencoed, United KingdomOnsiteFull TimeSenior$98,337 - $134,418 (estimated)Regulatory Affairs

About this role

QuidelOrtho is hiring a Senior Regulatory Affairs Associate to join its Clinical Laboratories business in Pencoed on a permanent basis. The role supports both ongoing regulatory operations and new product development initiatives within the Regulatory Affairs department, coordinating regulatory submissions and helping maintain compliance for marketed diagnostic products. The position operates with minimal oversight and interfaces with internal partners and external health authorities.

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Required Skills

Regulatory Submissions
FDA 510(k)
BLA Submissions
EU IVDR
Notified Body
Lifecycle Management
Labeling Review
Change Management
Regulatory Strategy
Technical Files

+4 more

Qualifications

Bachelor’s Degree

About Ortho Clinical Diagnostics

quidelortho.com

We invite you to connect with us and explore how our diagnostic portfolio can make a difference in your healthcare setting. Together, we can work toward a healthier future by leveraging advanced diagnostics to improve patient care, safety and treatment decisions.

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