California Licensed Regulatory Affairs Director

To ensure compliance with medical device regulations, the full-time California Licensed Regulatory Affairs Director will manage regulatory submissions, maintain regulatory files, and support post-market activities while working remotely. Key responsibilities Write and compile technical documents for country-specific regulatory submissions, ensuring adherence to applicable guidance documents Maintain and update regulatory authorizations and registrations, including 510(k)s and CE Technical Files Assess device-related incidents for reporting requirements and handle recalls and field actions as necessary Required qualifications Bachelor's degree in Engineering, Science, or a related scientific discipline Minimum of 4 years of experience in a medical device environment Working knowledge of regulations, standards, and guidelines related to regulatory affairs Strong analytical skills with the ability to digest complex data while maintaining a big-picture perspective Proficient in technical systems, including MS Office applications and databases