Regulatory Manager- IVD and 510(k)
CorDx(8 months ago)
About this role
CorDx is a multinational biotechnology company developing point-of-care diagnostic and IVD solutions for global health. The Regulatory Manager - IVD and 510(k) will be part of the Regulatory Affairs team in San Diego, focusing on regulatory strategy and submissions to ensure products meet FDA and other regulatory requirements. This is a full-time, onsite role supporting the company’s commercialization efforts.
Required Skills
- 510k Submissions
- Regulatory Compliance
- Risk Assessment
- Documentation
- FDA Interactions
- Labeling Review
- Project Management
- Stakeholder Liaison
Qualifications
- Bachelor's Degree in Life Sciences or Biotechnology
- RAC Certification (preferred)
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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