Manager/Senior Manager Regulatory Affairs

BioTalent; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

BioTalent in San Diego is seeking a Manager/Senior Manager, Regulatory Affairs to lead regulatory strategy for a Class III active implantable platform. You will own regulatory readiness across software, firmware, and hardware throughout the product lifecycle.

You will author IDE, PMA and supplements, guide AI/ML features regulatory path, coordinate with engineering, quality and clinical teams, and represent the company in FDA discussions.

Qualifications

• 10+ years in medical device regulatory affairs.
• Experience with IDE, PMA, and PMA supplements.
• Strong knowledge of 21 CFR Parts 820, 812, 814.
• Experience with AI/ML-enabled devices regulatory.
• Ability to lead FDA interactions independently.
• Experience supporting manufacturing regulatory considerations.

Responsibilities

• Lead regulatory strategy for software, firmware, and hardware programs.
• Author IDE, PMA, and PMA supplements submissions.
• Develop regulatory strategy for AI/ML features.
• Support manufacturing changes and design transfers.
• Partner with engineering, quality, clinical, operations.
• Guide concept and design inputs through submission.
• Monitor evolving FDA regs and international standards.
• Represent company in FDA meetings and pre-submissions.
• Travel limited to under 10%.

Skills

Regulatory affairs

FDA submissions

Software regulatory

AI/ML regulation

Regulatory strategy

Cross-functional collaboration

Communication

Education

Bachelor's degree in engineering or life sciences

Advanced degree preferred

Job description

Manager/Senior Manager, Regulatory Affairs

(fully on-site 5x per week in San Diego)

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 Regulatory Manager/Senior Manager 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
• 10+ years of regulatory affairs experience in the medical device industry, including demonstrated experience with complex HW/SW based 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