Sr Regulatory Affairs Manager
Ortho Clinical Diagnostics(6 days ago)
About this role
This role at QuidelOrtho involves managing regulatory activities for in vitro diagnostics and medical devices, supporting product development, regulatory submissions, and compliance. The position requires collaboration with cross-functional teams and regulatory agencies to ensure product approval and adherence to worldwide regulations.
Required Skills
- Regulatory Submissions
- FDA
- IVDR
- ISO
- QSR
- Medical Devices
- Regulatory Strategy
- Product Development
- GMP
- International Regulations
Qualifications
- BS in a scientific discipline
- 12 years experience in IVD/medical device industry
- Experience in regulatory documentation and submissions
- Leadership in regulatory disciplines
- Interaction with FDA and global agencies
About Ortho Clinical Diagnostics
quidelortho.comWe 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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