Be at the forefront of neurotechnology as the Director of Regulatory Affairs for Epia Neuro in Alameda, California, overseeing FDA interactions and regulatory strategy for innovative medical devices.
In this role, reporting to the CEO, you will establish and execute the regulatory strategy, navigating the path from early FDA engagement to PMA submissions. Your leadership will directly influence the alignment of technical and non-technical teams to ensure compliance with regulatory requirements while fostering patient outcomes.
Key Responsibilities:
• Act as the main interface with regulatory authorities
• Own the global regulatory strategy through to PMA approval
• Lead submissions including IDEs and Breakthrough Device Designations
• Collaborate with development and clinical teams for alignment
• Establish regulatory strategy while ensuring execution integrity
Requirements:
• Biomedical engineering or life sciences degree
• Minimum of 7-9 years in Regulat...