Regulatory & Compliance Specialist
CorDx(1 year ago)
About this role
CorDx is a multinational biotech company delivering point-of-care diagnostic solutions for infectious disease and other health conditions. The Regulatory & Compliance Specialist role supports in vitro diagnostic product development by ensuring processes and documentation meet applicable regulatory and quality standards. The position works with cross-functional teams to maintain regulatory readiness for product development and inspections.
Required Skills
- Regulatory Compliance
- ISO 13485
- FDA Regulations
- Risk Management
- Design Control
- Regulatory Submissions
- Documentation
- Quality Assurance
- Communication
- Problem Solving
Qualifications
- Bachelor's Degree
- RAC
- CQE
- CQA
About CorDx
cordx.comCorDx is a global diagnostics organization dedicated to delivering essential health insights. The company partners with various organizations worldwide to develop, manufacture, and supply diagnostic tools that empower users to monitor and enhance their health. CorDx's innovative solutions help individuals make informed health decisions, ensuring timely access to critical information.
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