Regulatory Affairs Manager - IVD

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