Senior Director, Regulatory Affairs — MedTech & AI/ML

Synchron Inc.; California; Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Synchron Inc. is seeking a Senior Director of Regulatory Affairs for our San Diego site, overseeing regulatory activities across software, firmware, and hardware. You will own regulatory strategy for new BCI platform development and lead submissions with cross-functional teams.

You will partner with engineering, quality, clinical, and operations to ensure regulatory readiness throughout the product lifecycle, support IDE/PMAs, and interact with the FDA as needed.

Qualifikationen

• Bachelor’s degree in engineering, life sciences, or related field; advanced degree preferred.
• 12+ years regulatory affairs experience in medical devices, with progressive responsibility including Class III devices.
• Experience with IDE, PMA, and supplements and FDA interactions.
• Strong software and firmware regulatory expertise for complex medical devices (AI/ML features).
• Deep knowledge of 21 CFR Parts 820, 812, 814 and applicable international standards.
• Exceptional written and verbal communication; ability to translate regulatory complexity for engineering/executive audiences.

Aufgaben

• Lead regulatory strategy and submission planning for software, firmware, and hardware in new product development.
• Partner with engineering, quality, clinical, and operations to integrate regulatory requirements.
• Represent Synchron in FDA meetings, pre-submission interactions, and agency correspondence.
• Support manufacturing-related regulatory activities and design transfers.
• Monitor evolving FDA regulations and international standards for Class III devices.

Kenntnisse

Regulatory leadership

Cross-functional collaboration

Strategic planning

Communication skills

Time management

Regulatory strategy

Risk assessment

Ausbildung

Bachelor's degree in engineering, life sciences, or related field

Advanced degree preferred

Jobbeschreibung

Job Description

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)
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 (<10% of the time). Potential planned travel for FDA meetings, cross-site collaboration, and conferences.
• 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 ext