Associate Regulatory Affairs Manager – Medical Devices

CorDx; San Diego (CA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Highly competitive compensation

Medical, dental, vision insurance

401(k) plan with company contributions

Flexible PTO

Additional substantial benefits

Job summary

CorDx is seeking an Associate Regulatory Affairs Manager to support development, review, and submission of regulatory documents for medical devices and IVD products. You will ensure FDA and ISO 13485 compliance, coordinate with internal teams and external partners, and drive timely approvals across a global lifecycle.

The role requires a Master’s degree and 4–6 years’ experience with 510(k) submissions, audits, and strong project coordination.

Qualifications

• Master's level degree required or equivalent.
• Experience with 510(k) submissions and regulatory filings.
• Strong organizational and project coordination skills.
• Excellent communication and cross‑functional collaboration abilities.
• Detail‑oriented with ability to manage multiple projects.

Responsibilities

• Assist in preparing, reviewing, and submitting regulatory documentation for new products and changes.
• Support 510(k) submissions, Technical Files, and other filings.
• Provide regulatory guidance to cross‑functional teams during development and post‑market activities.
• Track submission timelines and regulatory project plans.

Skills

Regulatory submissions

FDA regulatory

Cross-functional collaboration

Regulatory audits

Documentation management

Education

Master's degree in Regulatory Affairs/Life Sciences/Engineering

Job description

CorDx is seeking an Associate Regulatory Affairs Manager to support development, review, and submission of regulatory documents for medical devices and IVD products. You will ensure FDA and ISO 13485 compliance, coordinate with internal teams and external partners, and drive timely approvals across a global lifecycle.

The role requires a Master’s degree and 4–6 years’ experience with 510(k) submissions, audits, and strong project coordination.