Senior Director, Regulatory Affairs-CA

About the role

The Senior Director of Regulatory Affairs will serve as the senior regulatory leader for Synchron’s San Diego operations, providing strategic and operational oversight across software, firmware, and hardware regulatory activities. This role will own regulatory strategy for new BCI platform development, with oversight of ongoing product updates, and manufacturing-related submissions, working closely with cross-functional teams in engineering, quality, and clinical to ensure regulatory readiness at every stage of the product lifecycle.

Key Responsibilities

• Regulatory Strategy and Submissions
  • Lead regulatory strategy and submission planning for software, firmware, and hardware for new product development programs and product updates
  • Author and manage IDE, PMA, and PMA supplement submissions to the FDA; support additional international filings as needed
  • Develop and execute software and firmware regulatory strategy for complex BCI devices, including AI/ML considerations, software and firmware change management, and lifecycle documentation in compliance with applicable guidance
  • Provide regulatory support for manufacturing-related activities, including process changes and design transfers
• Cross-Functional Leadership
  • Partner with engineering, software, quality, clinical, and operations teams to integrate regulatory requirements from early development through commercialization
  • Provide regulatory guidance on new product concepts, design inputs, and technology transfers
  • Support project planning and roadmaps with well-defined regulatory milestones and risk assessments
• Regulatory Intelligence and Compliance
  • Maintain regulatory intelligence and ensure ongoing compliance with IDE and approved submission commitments, including reporting obligations and correspondence management
  • Represent Synchron in FDA meetings, pre-submission interactions, and agency correspondence

Required Qualifications

• Bachelor’s degree in engineering, life sciences, or a related field; advanced degree preferred
• 12+ years of regulatory affairs experience in the medical device industry, with progressive responsibility including demonstrated experience with complex, high-risk (Class III) active implantable neurological or cardiac devices
• Strong software and firmware regulatory expertise for complex medical devices, including experience with AI/ML-enabled features, software and firmware change management, and applicable FDA guidance
• Track record of leading FDA submissions (IDE, PMA, supplements) and managing agency interactions independently
• Familiarity with manufacturing-related regulatory considerations, including process changes and design transfers, in a device development or scale-up context
• Experience supporting new product development from concept through submission, including design control and risk management integration
• Deep knowledge of 21 CFR Parts 820, 812, 814, and applicable international standards
• Exceptional written and verbal communication skills; ability to translate regulatory complexity for engineering and executive audiences
• Effective time management and interpersonal skills

Preferred Qualifications

• RAC certification (RAPS)
• Experience with brain-computer interfaces, neural stimulation, or implantable neurotechnology
• Familiarity with OUS regulatory pathways (CE Mark, TGA, or similar)
• Experience scaling a regulatory function at a growth-stage medical device company