Regulatory Affairs Specialist
Cepheid(1 month ago)
About this role
The Regulatory Affairs Specialist at Radiometer is a member of the global regulatory affairs team responsible for ensuring regulatory compliance for diagnostic and medical device products across their lifecycle. The role is based in north Bengaluru, reports to the Principal Specialist, Regulatory Affairs, and operates on-site as part of Radiometer (a Danaher company). This position interfaces with global stakeholders to support product registrations and maintain adherence to international regulatory frameworks.
Required Skills
- Regulatory Strategy
- Change Assessments
- Regulatory Documentation
- Submissions Management
- Compliance
- Risk Assessment
- Design Control
- Postmarket Surveillance
- Standards Interpretation
- Audit Readiness
+1 more
Qualifications
- Bachelor's Degree
- Master's Degree
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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