Senior Director, Regulatory Affairs-CA

Synchron Inc. • San Diego, CA

12d • $210,000 - $240,000 • Onsite

About The Position

We are seeking a Senior Director of Regulatory Affairs who 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.

Requirements

• 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
• Builds productive internal and external working relationships

Nice To Haves

• 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

Responsibilities

• 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
• 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
• Monitor evolving FDA regulations, guidance documents, and international standards relevant to Class III implantable devices and complex software- and firmware-driven medical technologies
• 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
• Perform other duties and responsibilities as assigned

Benefits

• Subsidized medical and dental insurance coverage for you and your dependent(s)
• Life insurance, short-term disability, long-term disability
• 401k
• Discretionary unlimited PTO
• Flexible Spending Account for you and your dependent(s), with eligible plan elections
• Commuter benefits for NY employees

What This Job Offers

• Job Type: Full-time
• Career Level: Director