IVD Regulatory & Quality Specialist – FDA/ISO Expert

CorDx; San Diego (CA); On-site; USD 90,000 - 95,000; Full time

Benefits offered by this job

Medical Insurance Plan

Retirement Plan

Paid Time Off

Training & Development

Job summary

CorDx in San Diego seeks a Regulatory & Compliance Specialist to ensure product development and manufacturing meet FDA, ISO, and global standards.

You will guide regulatory strategy, manage risk files, review design history, and support De Novo/510(k) submissions. The role requires cross-functional collaboration, meticulous documentation, and audit readiness.

Join a dynamic team driving quality, regulatory excellence, and patient-safe diagnostics in a fast-paced biotech environment.

Qualifications

• Bachelor degree or equivalent in life sciences, engineering or regulatory fields.
• Advanced degree or RAC/CQE/CQA is a plus.
• 3+ years in regulatory affairs or quality/compliance in medical devices or IVD.
• Experience with 510(k) and CE submissions preferred.

Responsibilities

• Ensure regulatory compliance for IVD products per FDA 21 CFR Part 820 and ISO 13485.
• Provide regulatory guidance during product development and risk management.
• Prepare regulatory submissions (De Novo, 510(k)) and support inspections.
• Review and approve design history files and documentation for regulatory readiness.

Skills

Regulatory compliance

Risk management

FDA regulations

ISO 13485

Regulatory submissions

Documentation & QA

Communication skills

Education

Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs or Quality Management

Regulatory Affairs certification (RAC) or CQE/CQA (plus)

Job description

CorDx in San Diego seeks a Regulatory & Compliance Specialist to ensure product development and manufacturing meet FDA, ISO, and global standards.

You will guide regulatory strategy, manage risk files, review design history, and support De Novo/510(k) submissions. The role requires cross-functional collaboration, meticulous documentation, and audit readiness.

Join a dynamic team driving quality, regulatory excellence, and patient-safe diagnostics in a fast-paced biotech environment.