Senior Regulatory Lead - Robotic Surgery Devices (Remote)

Johnson Johnson; Santa Clara (CA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group in Santa Clara, CA. This role leads regulatory strategy across development, submissions, and lifecycle management for electromechanical, software-enabled devices.

You will collaborate with engineering and clinical teams to generate submission-ready documentation, manage health authority communications, and help expand US and international market access.

Qualifications

• Bachelor's degree required; Advanced Degree strongly preferred.
• 6+ years regulatory affairs experience in medical devices including software-enabled systems.
• Proven track record of securing regulatory approvals (510(k)s, IDEs, De Novo).
• Excellent cross-functional communicator; able to influence within the regulatory team and across functions.
• Independent strategic thinker; synthesize regulatory information to drive business priorities.
• Experience supporting US market; travel up to 10%.

Responsibilities

• Prepare and execute regulatory strategies for NPD and LCM projects.
• Serve as strategic regulatory lead across product development, submission, approval, and LCM activities.
• Act as a regulatory SME on cross-functional partners with software-enabled devices.
• Prepare and file FDA submissions (Q-submissions, IDEs, De Novo, 510(k)s) and lead FDA meetings.
• Execute sustaining activities including change assessments, Letter To File, registrations and renewals.
• Support global health authorities' submissions technical documents.
• Apply expert knowledge of guidances, regulations, and standards relevant to product portfolio.
• Support audits.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory approvals

Regulatory leadership

Education

Bachelor's degree

Advanced degree

Tools

Software-enabled devices

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group in Santa Clara, CA. This role leads regulatory strategy across development, submissions, and lifecycle management for electromechanical, software-enabled devices.

You will collaborate with engineering and clinical teams to generate submission-ready documentation, manage health authority communications, and help expand US and international market access.