Whitney Rooker
Regulatory Affairs Professional | Medical Devices & IVDs | Global Submissions & Market Access
- Role
- Senior Regulatory Affairs Specialist at Meridian Bioscience Inc.
- Location
- Birmingham, AL, US
- LinkedIn followers
- 500 followers
About Whitney Rooker
Regulatory Affairs professional specializing in Medical Devices and In Vitro Diagnostics (IVDs), with experience in global regulatory strategy, submissions, and lifecycle management, supported by a background in Quality Assurance. Experienced in EU MDR and IVDR and navigating global regulatory frameworks to drive compliance, support market access, and ensure timely product approvals. Committed to aligning regulatory requirements with business objectives while maintaining the highest standards of safety, performance, and compliance.
Experience
Senior Regulatory Affairs Specialist
Feb 2022 — Present
Education
The University of Southern Mississippi
Bachelor of Science - BS, Biology/Biological Sciences, General
2009 — 2013
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