Regulatory Affairs Leader, MedTech Robotics & Surgery

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); Hybrid; USD 157,000 - 271,000; Full time

Job summary

Johnson & Johnson is seeking an Associate Director, Regulatory Affairs to support our Robotics & Digital Solutions group in Santa Clara, CA. This role will work a Flex/Hybrid schedule with 3 days on-site, and relocation assistance may be provided.

You will lead regulatory strategy for software and vision subsystems across development, submissions, and lifecycle management, ensuring timely market access in the US and globally.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 10+ years of regulatory affairs experience in medical devices including software-enabled systems.
• 2+ years of demonstrated people-management experience including direct reports, coaching, and performance management.
• Proven track record of securing regulatory approvals for software enabled devices.
• Strong knowledge of FDA software and cybersecurity regulatory requirements.
• Proven ability to lead complex programs independently.
• Experienced managing multiple projects with complex level of detail.
• Strong verbal and written communications skills.
• Experience with US, EU MDR, and other global markets.
• Experience with vision systems, robotics, and connected medical platforms.

Responsibilities

• Serve as regulatory leader for software and vision subsystems across product development, submission, approval, and LCM activities.
• Define and execute regulatory strategies for software subsystem, vision systems, endoscopes, and integrated robotic system; including NPD and LCM stages.
• Obtain timely market access for new product introduction and enable lifecycle management activities in the US and support OUS activities.
• Manage premarket regulatory submissions to US FDA including 510(k)s, IDE, Q-Subs, etc. as well as sustaining activities including change assessments, Letter To File, registrations and renewals.
• Support and enable global registrations.
• Manage software and vision regulatory team- Lead and develop regulatory team members, serving as a coach and mentor.
• Manage internal resources or contractor SMEs to deliver submissions or other project objectives.
• Serve as regulatory subject matter expert to cross-functional partners with strong knowledge of software lifecycle, cybersecurity, and connected systems.
• Applies expert knowledge of guidance's, regulations, and standards relevant to product portfolio.
• Supports audits.

Skills

Regulatory leadership

People management

Cross-functional communication

FDA regulatory knowledge

Software in medical devices

Education

Bachelor's degree

Advanced degree preferred

Job description

Johnson & Johnson is seeking an Associate Director, Regulatory Affairs to support our Robotics & Digital Solutions group in Santa Clara, CA. This role will work a Flex/Hybrid schedule with 3 days on-site, and relocation assistance may be provided.

You will lead regulatory strategy for software and vision subsystems across development, submissions, and lifecycle management, ensuring timely market access in the US and globally.