Senior Regulatory Affairs Manager (Onsite)
CorDx(8 months ago)
About this role
A Senior Regulatory Affairs Manager at CorDx works within a multinational biotech focused on point-of-care diagnostic devices. The role is based onsite in Atlanta or San Diego and centers on leading regulatory strategy and interactions with regulatory authorities to enable product approvals and market launches.
Required Skills
- Regulatory Submissions
- FDA Interactions
- 510k
- ISO13485
- Quality Systems
- Project Management
- Leadership
- Communication
- Negotiation
- Problem Solving
+2 more
Qualifications
- Master's Degree in Regulatory Affairs, Life Sciences, or Engineering
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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