Regulatory Affairs Professional
Cepheid(1 month ago)
About this role
The Regulatory Affairs Professional at Radiometer (Danaher) coordinates regulatory activities for blood gas analyzers, immunoassay analyzers, consumables and accessories to ensure global compliance across the product lifecycle. The role partners with cross-functional teams in product development and maintenance to support registrations, change assessments, and regulatory interactions from Bengaluru, India.
Required Skills
- Regulatory Strategy
- Change Assessment
- Regulatory Documentation
- Submissions Management
- EU MDR/IVDR
- 510(k) Submissions
- Risk Assessment
- Design Control
- Audit Readiness
- Postmarket Surveillance
+1 more
Qualifications
- Bachelor's Degree (Science/Engineering/Pharmacy/Biology/Biotechnology/Medical Technology)
- Master's Degree (Science/Engineering/Pharmacy/Biology/Biotechnology/Medical Technology)
About Cepheid
cepheid.comCepheid is delivering a better way to improve patient outcomes by enabling access to molecular diagnostic testing everywhere.
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