Director Regulatory Affairs

BioTalent Ltd; San Diego (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

BioTalent Ltd is seeking a Senior Director, Regulatory Affairs in San Diego to lead regulatory strategy for a complex Class III implantable platform. You will oversee IDE, PMA submissions, and international filings, partnering with engineering, quality, and clinical teams to ensure regulatory readiness across software, firmware, and hardware throughout the product lifecycle.

The role requires deep knowledge of 21 CFR Parts 820, 812, 814, and hands-on experience guiding product development from

Qualifications

• Bachelor's degree in engineering, life sciences, or related field.
• 12+ years regulatory affairs experience in medical devices (Class II/III).
• Strong software and firmware regulatory expertise, incl AI/ML features.
• Proven track record leading FDA IDE, PMA submissions and agency interactions.
• Familiarity with manufacturing-related regulatory considerations.
• Deep knowledge of 21 CFR Parts 820, 812, 814 and applicable standards.

Responsibilities

• Lead regulatory strategy and submission planning for software, firmware, and hardware.
• Author and manage IDE, PMA, and supplements with FDA; support international filings.
• Develop regulatory strategy for AI/ML features in implantables.
• Provide regulatory support for manufacturing-related activities and design transfers.
• Collaborate with engineering, quality, clinical, and operations to ensure readiness.
• Advise on new product concepts, design inputs, and technology transfers.
• Track and interpret evolving FDA regulations and international standards.
• Ensure IDE commitments and submission reporting obligations are met.
• Represent the company in FDA meetings and pre-submission interactions.
• Travel minimal (<10%) for FDA meetings and cross-site work.

Skills

Regulatory strategy

FDA submissions

AI/ML in regulatory

Cross-functional leadership

Regulatory compliance

Education

Bachelor's degree in engineering / life sciences

Advanced degree preferred

Job description

Senior Director, Regulatory Affairs

Summary

Our client is a well-funded, growth-stage medical technology company developing a Class III active implantable platform at the intersection of healthcare and advanced engineering. This role serves as the senior regulatory leader for the company's San Diego operations, providing strategic and operational oversight across software, firmware, and hardware regulatory activities. The Senior Director will own regulatory strategy for new platform development, oversee ongoing product updates and manufacturing-related submissions, and work closely with engineering, quality, and clinical teams to ensure regulatory readiness throughout the product lifecycle.

Responsibilities

• Lead regulatory strategy and submission planning for software, firmware, and hardware across 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 implantable devices, including AI/ML considerations, change management, and lifecycle documentation
• 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, and international standards relevant to Class III implantable devices and complex software/firmware-driven medical technologies
• Ensure ongoing compliance with IDE and approved submission commitments, including reporting obligations
• Represent the company in FDA meetings, pre-submission interactions, and agency correspondence
• Minimal travel expected (<10%), with occasional travel for FDA meetings and cross-site collaboration.

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, including demonstrated experience with complex Class II or III Medical Devices.
• Strong software and firmware regulatory expertise, including AI/ML-enabled features and applicable FDA guidance
• Track record of independently leading FDA submissions (IDE, PMA, supplements) and managing agency interactions
• Familiarity with manufacturing-related regulatory considerations (process changes, 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
• Deep knowledge of 21 CFR Parts 820, 812, 814, and applicable international standards
• Exceptional written and verbal communication skills; able to translate regulatory complexity for engineering and executive audiences
• Comfortable operating in a lean, startup-style environment

Preferred:

• RAC certification (RAPS)
• experience with implantable neurotechnology or neural stimulation devices
• familiarity with OUS pathways (CE Mark, TGA)
• experience scaling a regulatory function at a growth-stage company