Regulatory Affairs Manager
Posted 19 Aug 2026
Advertised as “Regulatory Affairs Manager - IVD”
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 5+ yrs
- Management level
- People management
- Contract
- Full-time
No salary listed for this role.
Field of studyBiology, Biomedical Engineering, Chemistry, Clinical Laboratory Science, Life Sciences, Regulatory Science (or related)
Study levelBachelor's
CertificationsRAC
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 regulatory strategy and submissions for diagnostic products, including FDA 510(k), CLIA categorization/waiver activities, and other applicable regulatory pathways. The position will work closely with R&D, Clinical Affairs, Quality, Manufacturing, Product Management, and external partners throughout the product development lifecycle.
The ideal candidate has at least five years of regulatory affairs experience in the IVD or medical device industry, with hands-on experience preparing FDA submissions and interacting with FDA.
Company: CorDx Inc.
Location: San Diego, CA
Department: Regulatory Affairs / Compliance
Employment Type: Full-Time
Regulatory Strategy & Product Development
- Develop and execute U.S. regulatory strategies for new and existing IVD products.
- Determine appropriate regulatory pathways, product classification, predicate devices, and submission requirements.
- Provide regulatory guidance to R&D, Clinical, Quality, Manufacturing, and Product teams throughout product development.
- Participate in design and development activities and provide regulatory input regarding intended use, indications for use, labeling, performance requirements, and regulatory testing.
- Conduct regulatory assessments for product changes and determine whether new regulatory submissions or notifications are required.
FDA Submissions
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Lead preparation, review, and submission of FDA regulatory applications, including:
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510(k) Premarket Notifications
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CLIA Categorization and CLIA Waiver submissions
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Q-Submissions / Pre-Submissions
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Additional Information (AI) responses
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Other FDA submissions and regulatory correspondence as applicable
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Prepare and review regulatory submission sections covering device description, labeling, analytical performance, clinical performance, software, usability, risk management, and other applicable areas.
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Coordinate cross-functional submission activities and ensure submission documents are complete, consistent, accurate, and submitted according to project timelines.