Digital Health Regulatory Affairs Manager (AI)

Location: Remote within the United States; candidates may be located in any U.S. state or city

Salary: $117,000–$201,250 annual base pay, plus performance-based bonus eligibility

Company

Johnson & Johnson MedTech develops innovative medical technologies and cardiovascular solutions for heart recovery, electrophysiology, and stroke care.

What you will do

• Develop regulatory strategies to obtain FDA clearance or approval for new Class II and III cardiovascular medical devices and product improvements.
• Prepare and review FDA submissions, lead submission-material compilation, and communicate with FDA reviewers during pre-submission and review processes.
• Provide regulatory leadership for digital health products involving cybersecurity, SiMD, SaMD, AI/ML-based clinical decision support, and hardware.
• Support global regulatory teams by interpreting digital health regulations and guidance across geographies.
• Advise product development teams on regulatory issues, product changes, ongoing compliance, and regulatory filings.
• Maintain digital health regulatory procedures and negotiate with regulatory agencies on defined matters.

Requirements

• At least 6 years of Regulatory Affairs experience with a bachelor’s degree, or at least 5 years with an advanced degree.
• Degree in Computer Science, Engineering, or Science.
• Medical device regulatory experience with successful FDA submissions or FDA review experience in cybersecurity, SiMD, or SaMD.
• Experience communicating independently with FDA reviewers and leading Q-sub meetings or informal reviewer discussions.
• Knowledge of FDA requirements, ISO 14971, ISO 13485, IEC 60601, IEC 62304, IEC 82304, and cybersecurity requirements under Section 524B.
• Strong regulatory writing, communication, problem-solving, project management, and prioritization skills.

Nice to have

• Class III cardiovascular device experience and an engineering degree.
• AI/ML, PCCP, FDA review, or RAC certification experience.
• Successful IDE, PMA, or 510(k) submissions involving hardware and software components.

Culture & Benefits

• Remote work available across the United States.
• Inclusive work environment focused on diversity, dignity, and equal opportunity.
• Medical, dental, vision, life, disability, business accident, and group legal insurance may be available.
• Participation may be available in pension, 401(k), and long-term incentive programs.
• Vacation, sick time, holidays, and work, personal, and family time are provided according to applicable policies.