Associate Director, Regulatory Affairs – Robotics & MedTech

Biopharma Careers; Santa Clara (CA); On-site; USD 157,000 - 271,000; Full time

Job summary

Johnson & Johnson in Santa Clara, CA, seeks an Associate Director, Regulatory Affairs for Robotics & Digital Solutions. The role focuses on leading software and vision regulatory activities across development, submissions, and lifecycle management, with US and global registration responsibilities.

You will define regulatory strategies, manage teams, and ensure compliance with FDA software and cybersecurity requirements while partnering with diverse functions to advance medical device innovations.

Qualifications

• Bachelor’s degree is required; Advanced Degree strongly preferred.
• Experience securing regulatory approvals for software-enabled devices is required.
• Strong knowledge of FDA software and cybersecurity regulatory requirements is required.

Responsibilities

• Serve as regulatory leader for software and vision subsystems across product development, submission, approval, and lifecycle management.
• Define and execute regulatory strategies for software subsystem and vision systems; including development and lifecycle management.
• Obtain timely market access for new product introductions and support lifecycle management in US and OUS.
• Manage premarket regulatory submissions to US FDA including 510(k)s, IDE, Q-Subs, and related activities; support global registrations.
• Lead and develop regulatory team members; coach and mentor.
• Collaborate with cross-functional partners and ensure compliance with regulatory guidance and standards.

Skills

Regulatory leadership

Software regulatory

FDA submissions

People management

Cross-functional collaboration

Education

Bachelor's degree required

Advanced degree preferred

Job description

Johnson & Johnson in Santa Clara, CA, seeks an Associate Director, Regulatory Affairs for Robotics & Digital Solutions. The role focuses on leading software and vision regulatory activities across development, submissions, and lifecycle management, with US and global registration responsibilities.

You will define regulatory strategies, manage teams, and ensure compliance with FDA software and cybersecurity requirements while partnering with diverse functions to advance medical device innovations.