Remote Digital Health Regulatory Lead

Johnson & Johnson Innovative Medicine; United States; Remote; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Regulatory Affairs Manager- Digital Health to lead FDA submissions for Class II & III cardiovascular devices, and to align digital health products with global regulatory requirements. This role partners with cross-functional teams to ensure compliant design and submission readiness.

You will drive strategic regulatory input for cybersecurity, SiMD/SaMD, and AI/ML components, coordinate with product development, and interface with FDA during

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• Degree in Computer Science/Engineering or Science preferred.
• Regulatory Affairs experience in medical device industry with FDA submissions experience.
• Experience communicating with FDA reviewers and leading Q-sub meetings.
• Experience supporting software device development (SiMD, SaMD, Cybersecurity) and related standards.

Responsibilities

• Develop strategies to obtain FDA clearance or approval for Class II & III cardiovascular devices.
• Serve as liaison for global regulatory teams as product approvals expand geographically.
• Prepare and review FDA submissions and respond to FDA pre-submission feedback.
• Support global regulatory teams and interface with product development on Digital Health.
• Lead compilation of materials required for FDA submissions and maintain regulatory SOPs.

Skills

Regulatory affairs

FDA submissions

Regulatory writing

Cybersecurity in medical devices

SiMD/SaMD

Cross-functional leadership

Project management

Communication with FDA

Education

Bachelor’s degree

Advanced degree

Engineering/Computer Science preferred

Job description

Johnson & Johnson Innovative Medicine is seeking a Regulatory Affairs Manager- Digital Health to lead FDA submissions for Class II & III cardiovascular devices, and to align digital health products with global regulatory requirements. This role partners with cross-functional teams to ensure compliant design and submission readiness.

You will drive strategic regulatory input for cybersecurity, SiMD/SaMD, and AI/ML components, coordinate with product development, and interface with FDA during