Remote Digital Health Regulatory Leader (SiMD/AI)

Antler Co; Danvers (MA); Remote; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson is seeking a Regulatory Affairs Manager for Digital Health to lead FDA submissions, advise on global regulatory requirements, and coordinate with cross-functional teams across cardiovascular digital health platforms.

The role emphasizes cybersecurity, SiMD/SaMD, and AI/ML in a complex medical device ecosystem, with an emphasis on ensuring compliant, timely product approvals and lifecycle management.

Qualifications

• Regulatory Affairs experience in the medical device industry with a track record of FDA submissions including cybersecurity (524B) and software/hardware components.
• Experience with complex networked device ecosystems and regulatory submissions for SaMD/SiMD.
• Familiarity with FDA requirements, ISO standards (14971, 13485) and cross-functional collaboration.

Responsibilities

• Lead cross-functional new product development projects focusing on cybersecurity, software (SiMD/SaMD/AI) and hardware; compile FDA submission materials.
• Provide regulatory support for global digital health submissions and guidance to project teams.
• Support ongoing compliance for marketed products and assess regulatory changes for product updates.
• Monitor evolving global digital health regulations and maintain regulatory SOPs.

Skills

Regulatory affairs

FDA submissions

Cybersecurity

SiMD SaMD

AI/ML

Regulatory leadership

Cross-functional teamwork

Education

Degree in CS/Engineering

Advanced degree

Job description

Johnson & Johnson is seeking a Regulatory Affairs Manager for Digital Health to lead FDA submissions, advise on global regulatory requirements, and coordinate with cross-functional teams across cardiovascular digital health platforms.

The role emphasizes cybersecurity, SiMD/SaMD, and AI/ML in a complex medical device ecosystem, with an emphasis on ensuring compliant, timely product approvals and lifecycle management.