Digital Health Regulatory Affairs Manager

About the role

Johnson & Johnson is seeking a Digital Health Regulatory Affairs Manager to lead regulatory strategy for Class II & III cardiovascular medical devices and digital health solutions. This remote position supports global product approvals and works closely with cross‑functional teams.

Key responsibilities

• Develop and execute regulatory strategies to obtain FDA clearance or approval for new and improved cardiovascular devices.
• Prepare, review, and submit FDA documentation, including pre‑submission interactions and Q‑sub meetings.
• Provide regulatory guidance on cybersecurity, software (SiMD, SaMD, AI/ML), and hardware components across the product portfolio.
• Support global regulatory teams and act as liaison with product development and clinical offices.
• Monitor and interpret global digital health regulations, updating SOPs and ensuring ongoing compliance for marketed products.

Required profile

• Minimum 5‑6 years of Regulatory Affairs experience in the medical device industry with successful FDA submissions for Class III devices.
• Proven track record with cybersecurity (524B), SiMD, SaMD, and AI/ML‑based clinical decision support.
• Experience working with complex networked device ecosystems (e.g., cardiac electrophysiology, neuromodulation, robotic surgery).
• Strong leadership, communication, and cross‑functional teamwork skills.

Required skills

• FDA submission preparation and interaction (IDE, PMA, 510(k)).
• Cybersecurity compliance (524B), IEC 62304/82304.
• Regulatory standards: ISO 14971, ISO 13485, IEC 60601.
• Software classifications: SiMD, SaMD, AI/ML.
• Regulatory intelligence and policy analysis for global markets.