California Licensed Regulatory Affairs Director

Job Summary

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