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 RoleWe 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 (
- Perform other duties and responsibilities as assigned
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
- Builds productive internal and external working relationships
Preferred Qualifications- 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
Key Competencies- Strong attention to detail and commitment to accuracy
- Excellent problem-solving
- Effective written and verbal communication
- Ability to partner cross-functionally and influence stakeholders
- Strong organizational and project management skills, with comfort operating in a lean, startup-style environment
CompensationThe base salary range for this role is
$210,000 - $240,000 depending on experience, skills, and qualifications.
In addition to base salary, this role may be eligible for
discretionary bonuses and/or equity grants, subject to board approval and company policy.
Visa Sponsorship We are unable to offer visa sponsorship for this position currently.
Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible- 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
