Remote Digital Health Regulatory Affairs Manager

Johnson & Johnson Innovation; Danvers (MA); Remote; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson is seeking a Regulatory Affairs Manager - Digital Health to lead FDA submissions for Class II/III cardiovascular devices, with a focus on cybersecurity and software components.

You will partner with global regulatory teams to interpret regulations, prepare submissions, and guide product development across the Digital Health portfolio, ensuring compliance and timely approvals. This is a remote role open to candidates nationwide in the United States.

Qualifications

• Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions (including cybersecurity 524B) and software/hardware components.
• Experience with IDE/PMA/510(k) device submissions (Class III preferred) and interaction with FDA reviewers.
• Strong regulatory writing and communication skills.
• Ability to manage multiple projects and lead Q-sub meetings or informal discussions with reviewers.

Responsibilities

• Support cross-functional new product development with a focus on cybersecurity, SiMD/SaMD, and hardware for FDA submissions.
• Provide regulatory support for currently marketed products to ensure ongoing compliance.
• Interact with FDA reviewers and lead Q-sub meetings as needed.
• Support global regulatory strategies and advise on global requirements for digital health products.
• Interface with product development teams in Digital Health to ensure compliant design and documentation.

Skills

Regulatory Affairs

FDA submissions

Cybersecurity

SiMD SaMD

Regulatory writing

Education

Bachelor's degree

Job description

Johnson & Johnson is seeking a Regulatory Affairs Manager - Digital Health to lead FDA submissions for Class II/III cardiovascular devices, with a focus on cybersecurity and software components.

You will partner with global regulatory teams to interpret regulations, prepare submissions, and guide product development across the Digital Health portfolio, ensuring compliance and timely approvals. This is a remote role open to candidates nationwide in the United States.