Regulatory Lead: Software & Robotics MedTech (Hybrid)

Antler; Santa Clara (CA); Hybrid; USD 157,000 - 271,000; Full time

Benefits offered by this job

Pension plan

401(k) plan

Vacation leave

Parental leave

Bereavement leave

Job summary

Johnson & Johnson is seeking an Associate Director, Regulatory Affairs to lead software and vision subsystem regulatory efforts for Robotics & Digital Solutions in a hybrid Santa Clara, CA role. You will drive regulatory strategy across development, submissions, and lifecycle management, coordinating a cross-functional team to ensure timely market access.

You will oversee US FDA submissions (510(k), IDE, etc.), support global registrations, and mentor the regulatory team while applying deep

Qualifications

• Bachelor’s degree required; Advanced Degree strongly preferred.
• 10+ years of regulatory affairs experience in medical devices including software-enabled systems.
• 2+ years of people-management experience with direct reports and performance management.
• Proven track record of securing regulatory approvals for software-enabled devices.
• Strong knowledge of FDA software and cybersecurity regulatory requirements.
• Experience leading complex programs independently and cross-functionally.
• Experience with US, EU MDR and global markets.
• Experience with vision systems, robotics and connected medical platforms.

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 integrated robotic systems.
• Obtain timely market access for new product introductions and lifecycle management in US and support for OUS.
• Manage premarket regulatory submissions to US FDA including 510(k)s, IDE, Q-Subs; support global registrations and renewals.
• Lead and develop regulatory team members; coach and mentor.
• Coordinate internal resources or contractors to deliver submissions and other project objectives.
• Serve as regulatory SME to cross-functional partners with strong knowledge of software lifecycle, cybersecurity, and connected systems.
• Apply knowledge of guidance documents, regulations and standards relevant to the portfolio.
• Support audits.

Skills

Regulatory leadership

Software regulatory

Cross-functional collaboration

FDA submissions

Cybersecurity knowledge

Team coaching

Strategic regulatory planning

Education

Bachelor's degree

Advanced degree

Job description

Johnson & Johnson is seeking an Associate Director, Regulatory Affairs to lead software and vision subsystem regulatory efforts for Robotics & Digital Solutions in a hybrid Santa Clara, CA role. You will drive regulatory strategy across development, submissions, and lifecycle management, coordinating a cross-functional team to ensure timely market access.

You will oversee US FDA submissions (510(k), IDE, etc.), support global registrations, and mentor the regulatory team while applying deep