California Licensed Regulatory Affairs Associate

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

Created: 2026-03-05