synchronSan Diego, CA
Senior Director, Regulatory Affairs-CA
Senior Director, Regulatory Affairs-CA
Senior Director, Regulatory Affairs-CA
synchronSan Diego, CA
yesterday
Electromedical and Electrotherapeutic Apparatus ManufacturingSurgical Appliance and Supplies ManufacturingSurgical and Medical Instrument Manufacturing
Apply for this role (opens in a new tab)Job Description
About Synchron:
Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Director, Regulatory Affairs
Location: San Diego, California (Onsite Full-Time, 5 Days per Week)
Department: Regulatory
Reports to: VP, Regulatory and Quality
About the Role:
We are seeking a 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
- 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
- Minimal travel expected (
Also on the board Same function, level within a rung
Level
Manager
Location
San Diego, CA
Occupation
Regulatory Affairs Managers
Industry
Electromedical and Electrotherapeutic Apparatus Manufacturing
Posted
yesterday