Senior Regulatory Leader for MedTech Robotics & Vision

Johnson & Johnson MedTech; Santa Clara (CA); Hybrid; USD 157,000 - 271,000; Full time

Benefits offered by this job

401(k) plan

Paid time off

Relocation assistance

Hybrid schedule

Job summary

Johnson & Johnson is seeking an Associate Director, Regulatory Affairs for our Robotics & Digital Solutions unit in Santa Clara, CA. This role leads regulatory strategy for software and vision subsystems across development and lifecycle management, with a strong focus on US FDA submissions and global registrations.

You will manage a regulatory team, collaborate cross-functionally, ensure compliance with FDA cybersecurity and software regulatory requirements, and guide programs from concept

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 10+ years in regulatory affairs for medical devices.
• 2+ years of people-management experience.
• Proven track record securing regulatory approvals for software-enabled devices.
• Strong knowledge of FDA software and cybersecurity regulations.

Responsibilities

• Serve as regulatory leader for software and vision subsystems across development, submission, approval, and lifecycle management.
• Define and execute regulatory strategies for software subsystems, vision systems, endoscopes, and robotic systems.
• Obtain timely market access for new product introductions and lifecycle management in US and support global registrations.
• Manage premarket submissions to US FDA (510(k), IDE, Q-Subs) and sustain activities including change assessments and renewals.
• Coach and mentor the regulatory team; coordinate internal resources and SMEs.
• Provide SME guidance to cross-functional partners on software lifecycle, cybersecurity, and connected systems.
• Apply knowledge of guidance and standards relevant to product portfolio to drive strategy.
• Support audits.

Skills

Regulatory strategy

Leadership/People management

FDA regulatory requirements

Software as a Medical Device (SaMD)

Cross-functional collaboration

Education

Bachelor’s degree in a relevant field

Advanced degree preferred

Job description

Johnson & Johnson is seeking an Associate Director, Regulatory Affairs for our Robotics & Digital Solutions unit in Santa Clara, CA. This role leads regulatory strategy for software and vision subsystems across development and lifecycle management, with a strong focus on US FDA submissions and global registrations.

You will manage a regulatory team, collaborate cross-functionally, ensure compliance with FDA cybersecurity and software regulatory requirements, and guide programs from concept