RA Specialist
Ortho Clinical Diagnostics(1 month ago)
About this role
QuidelOrtho is seeking a Regulatory Affairs (RA) Specialist to support regulatory submissions and product licensing activities for in vitro diagnostics/medical device products, with a strong focus on Korea’s MFDS. The role supports delivery of an overall regulatory plan and works closely with internal stakeholders and external agencies to enable timely registrations and ongoing product compliance. Over time, the position may expand into more strategic regulatory responsibilities as capability grows.
Required Skills
- Regulatory Submissions
- Regulatory Strategy
- MFDS Submissions
- Product Registration
- License Maintenance
- KGMP Compliance
- Document Management
- Agency Liaison
- Labeling
- IFU Development
+5 more
Qualifications
- Bachelor’s Degree
- Master’s Degree
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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