California Licensed Regulatory Affairs Associate

Job Summary

A company is looking for a Senior Regulatory Affairs Associate to provide regulatory leadership for their product portfolio with a focus on complex systems.

Key Responsibilities

• Lead regulatory strategy for new product development and lifecycle management initiatives
• Author and manage high-complexity US FDA pre-market submissions and EU IVDR Technical Documentation
• Conduct regulatory impact assessments for design changes and ensure compliance with cybersecurity requirements

Required Qualifications

• Bachelor's degree in a Scientific, Engineering, or Bio-Medical discipline
• 5-8 years of experience in the Medical Device or IVD industry
• 3-5 years of experience performing regulatory impact assessments for complex system modifications
• 3-5 years of experience with IVD Instrumentation and Software, including authoring relevant 510(k)/PMA sections
• Practical knowledge of FDA Cybersecurity Guidance and related submission components