Regulatory Affairs Manager
Ortho Clinical Diagnostics(3 days ago)
About this role
QuidelOrtho is seeking a Regulatory Affairs Manager to lead regulatory strategies for complex medical systems, focusing on product development and compliance across global markets. The role involves authoring high-level submissions, assessing design changes, and ensuring cybersecurity and digital health regulation adherence. It offers a remote work opportunity based in California.
Required Skills
- Regulatory Affairs
- Cybersecurity
- Medical Devices
- Software Validation
- Technical Documentation
- FDA Submissions
- Risk Management
- Global Registration
- Impact Assessments
- Cybersecurity Standards
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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