Regulatory Affairs Manager — In Vitro Diagnostic (IVD)

Job overview

The Regulatory Affairs Manager — In Vitro Diagnostic (IVD) role is onsite in San Diego, CA; compensation is not specified. The position supports CorDx’s development, registration, and lifecycle management of in vitro diagnostic medical devices in the United States, working with Regulatory Affairs / Compliance and cross-functional teams.

What you'll do

• Develop U.S. regulatory strategies and lead FDA submissions, including 510(k), CLIA, and Q-Submissions
• advise product teams on regulatory pathways and development
• review analytical and clinical performance materials and product labeling
• manage FDA questions and responses
• support quality-system compliance, audits, design reviews, and change control
• maintain regulatory procedures and records
• and mentor junior regulatory staff.

What we're looking for

Skills & competencies

regulatory affairs manager

ivd

san diego ca

cordx

fda 510(k)

clia waiver

medical devices

regulatory strategy

fda submissions

product lifecycle

full-time

Work arrangement

• Weekend coverage required

Benefits & perks

• Comprehensive medical insurance, a 401(k) plan with company contributions, and flexible paid time off.

Why this role

The posting seeks at least five years of regulatory affairs experience in IVD, medical devices, diagnostics, or a related regulated healthcare industry, including hands-on FDA submission experience.

About the employer

CorDx is hiring for this role. Industry: Other General Government Support. Sector: 92.