Regulatory Affairs Manager - Medical Devices & FDA Expert

CorDx; San Diego (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

PTO

Job summary

CorDx is seeking a Regulatory Affairs Manager to support preparation, review, and submission of regulatory documentation for medical device products. This onsite role in San Diego requires coordinating 510(k) submissions, ensuring FDA compliance, and collaborating with R&D, Quality, and Operations teams throughout the product lifecycle.

The ideal candidate has a bachelor’s degree in regulatory affairs or life sciences, 5–7 years of regulatory affairs experience in medical devices, and strong

Qualifications

• Bachelor’s degree in regulatory affairs or life sciences.
• 5–7+ years regulatory affairs in medical devices/IVD.
• Experience with FDA 510(k) submissions and regulatory documentation processes.
• Strong communication, organization, and project management skills.

Responsibilities

• Prepare, review, and coordinate regulatory submissions (510(k), technical files).
• Ensure compliance with FDA regulations, ISO 13485, and international standards.
• Provide regulatory guidance to product development teams.
• Monitor regulatory changes and assess impact on processes and products.
• Assess regulatory pathways for product changes and maintenance of records.

Skills

FDA regulations

ISO 13485

Regulatory submissions

Cross-functional collaboration

Project management

Education

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or related field

Master’s degree preferred

Job description

CorDx is seeking a Regulatory Affairs Manager to support preparation, review, and submission of regulatory documentation for medical device products. This onsite role in San Diego requires coordinating 510(k) submissions, ensuring FDA compliance, and collaborating with R&D, Quality, and Operations teams throughout the product lifecycle.

The ideal candidate has a bachelor’s degree in regulatory affairs or life sciences, 5–7 years of regulatory affairs experience in medical devices, and strong