Regulatory Affairs Specialist
Cepheid(1 month ago)
About this role
The Regulatory Affairs Specialist at Radiometer supports global regulatory compliance for diagnostics and life-science products across their lifecycles, working within a global Regulatory Affairs organization. The role is based in north Bengaluru, reports to the Principal Specialist, Regulatory Affairs, and interfaces with cross-functional and global stakeholders. Radiometer is a Danaher operating company focused on life sciences, diagnostics and biotechnology.
Required Skills
- Regulatory Strategy
- Change Assessments
- Technical Documentation
- Regulatory Submissions
- EU MDR
- FDA
- MDSAP
- Risk Management
- Post-Market
- Audits
+2 more
Qualifications
- Bachelor's Degree in Science/Engineering/Pharmacy/Biology/Biotechnology/Medical Technology or related field
- Master's Degree in Science/Engineering/Pharmacy/Biology/Biotechnology/Medical Technology or related field
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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