Senior Regulatory Affairs Manager - IVD Devices
CorDx
CorDx Inc. is seeking an experienced Regulatory Affairs Manager in San Diego, CA to lead regulatory strategy and FDA submissions for IVD products throughout development and lifecycle. You will collaborate with R&D, Clinical, Quality, and Manufacturing to ensure compliant product strategies and timing. The role requires at least five years of regulatory affairs experience in IVD/medical devices, hands‑on FDA submission work, and strong communication skills to coordinate across multiple teams. #J-18808-Ljbffr CorDx
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- ...Description Job Description CorDx Inc. is seeking an experienced Regulatory Affairs Manager to support the development, registration, and lifecycle management of in vitro diagnostic (IVD) medical devices in the United States. The Regulatory Affairs Manager will lead...SuggestedFull timeFlexible hours
- ..., CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such... ...in healthcare. Job Type: Full time Job Title: Senior Regulatory Affairs Manager Location: Onsite - Atlanta, or San Diego Position...SeniorFull timeFlexible hours
$90k - $150k
...and point-of-care medical device solutions used in the... ...motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal... ...a strong background in IVD (In Vitro Diagnostics) and... ...Job Title: Regulatory Manager - IVD and 510(K) Location...SuggestedFull time$132k - $172k
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...new paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls...SeniorFull timeTemporary workRemote workWorldwide$240k - $275k
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A global healthcare company is seeking a Regulatory Affairs Specialist III in San Diego, CA. This role focuses on ensuring regulatory compliance and global market access for in-vitro diagnostic (IVD) products. Candidates must have a Bachelor’s degree and at least 6 years...Senior- Beta Bionics, Inc. is seeking a Senior Android Software Engineer in San Diego, CA to design, build, and maintain Android applications that are integral to the iLet medical device ecosystem. The ideal candidate will combine strong software fundamentals with architecture...Senior
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A consulting firm is seeking a Senior Embedded Software Engineer for a contract role in San Diego, California. This position involves... ...designing and maintaining real-time embedded software for medical devices, requiring extensive experience in C/C++ and RTOS. The ideal...SeniorHourly payContract work$95 - $105 per hour
A leading consulting firm is seeking a Senior Software Engineer in San Diego, CA, specializing in C/C++ and embedded programming for safety-critical medical devices. The role involves designing and maintaining software, conducting testing, and resolving complex issues,...SeniorHourly payLong term contract- ...the underlying subsystems, collaborating across product and ML teams to deliver high-performance, reliable experiences on Android devices. The role emphasizes leadership, cross-team collaboration, and hands-on development, with opportunities to influence across the stack...Senior
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