Associate Regulatory Affairs Manager — Medical Devices and Diagnostics

Job overview

Associate Regulatory Affairs Manager — Medical Devices and Diagnostics is an onsite role in San Diego, CA. Compensation is not specified. CorDx develops rapid testing and point-of-care medical device solutions for global health. The role supports regulatory submissions and compliance throughout the product lifecycle. It coordinates documentation, timelines, assessments, audits, and regulatory communications with cross-functional teams and external partners to support product approvals and ongoing compliance.

What you'll do

• Prepare, review, and submit regulatory documentation for new products, product changes, and ongoing compliance
• support 510(k), Technical File, and other filings
• provide regulatory guidance to cross-functional teams under senior management direction
• track submission timelines and project plans
• monitor regulatory changes
• assess product modifications and submission strategies
• participate in audits, inspections, and agency communications as assigned
• maintain regulatory files and records
• may mentor junior staff or specialists on assigned projects.

What we're looking for

Skills & competencies

associate regulatory affairs manager

san diego ca

cordx

medical devices

diagnostics

regulatory submissions

510(k)

fda compliance

iso 13485

ivdr

mandarin speaking

master’s degree

medical insurance

401(k)

flexible pto

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision insurance
• 401(k) with company contributions
• flexible paid time off
• and additional benefits.

Why this role

The source title specifies Mandarin-speaking bilingual ability. The posting requires a master’s degree and 4–6 years supporting or managing 510(k) submissions and regulatory filings.

About the employer

CorDx is hiring for this role. Industry: All Other Outpatient Care Centers. Sector: 62.