Sr. Regulatory Affairs Lead, Robotic Surgery Systems (Remote)

Johnson & Johnson MedTech; Santa Clara (CA); Hybrid; USD 125,000 - 201,000; Full time

Benefits offered by this job

Vacation –120 hours per calendar year

Sick time – 40 hours per calendar year

Holiday pay – 13 days per calendar ye

Parental Leave – 480 hours within one

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support OTTAVA robotics. The role leads regulatory strategy for NPD/LCM, collaborating with engineering and clinical teams to drive submissions and health authority communications.

This position may require travel and is based near Santa Clara, CA with possible remote options on a case-by-case basis. The candidate will manage regulatory submissions, maintain compliance with FDA requirements, and contribute to the global

Qualifications

• Bachelor’s degree required; advanced degree strongly preferred.
• 6+ years of regulatory affairs experience in medical devices including software-enabled systems.
• Proven track record of securing regulatory approvals (e.g., 510(k)s, IDEs, De Novo).

Responsibilities

• Prepare and execute regulatory strategies for NPD and LCM projects.
• Serve as strategic regulatory lead across product development, submission, approval, and LCM activities.
• Lead FDA meeting preparation and regulatory submissions (Q-submissions, IDEs, De Novo, 510(k)s).
• Support audits and global health authorities’ submissions as needed.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory strategy

FDA submissions

Education

Bachelor's degree

Advanced degree preferred

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support OTTAVA robotics. The role leads regulatory strategy for NPD/LCM, collaborating with engineering and clinical teams to drive submissions and health authority communications.

This position may require travel and is based near Santa Clara, CA with possible remote options on a case-by-case basis. The candidate will manage regulatory submissions, maintain compliance with FDA requirements, and contribute to the global