Associate Director, Regulatory Affairs (Robotics & Digital Solutions) - MedTech Surgery

Johnson & Johnson•Santa Clara, CA

1d•Hybrid

About The Position

This role will support the Robotics & Digital Solutions group within the Surgery team at Johnson & Johnson. The team is focused on developing the next generation of smarter, less invasive, and more personalized surgical treatments. The Associate Director will be a regulatory leader for software and vision subsystems, guiding product development from inception through submission, approval, and lifecycle management. This position offers a Flex/Hybrid schedule, requiring three days per week on-site in Santa Clara, CA. Relocation assistance may be provided on a case-by-case basis.

Requirements

Minimum of a Bachelor’s degree is required.
At least 10+ years of regulatory affairs experience in medical devices including experience with software-enabled systems.
2+ years of demonstrated people-management experience including direct reports, coaching, and performance management required.
Proven track record of securing regulatory approvals for software enabled devices required.
Strong knowledge of FDA software and cybersecurity regulatory requirements required.
Proven ability to lead complex programs independently.
Proven ability to be highly collaborative & flexible – comfortable navigating through ambiguity.
Excellent cross‑functional communicator; able to influence within the regulatory team and across functions.
Independent strategic thinker, able to synthesize regulatory pertinent information (guidance’s, regulations, trends., etc.) to provide regulatory strategy that drives towards business priorities/needs & demonstrates view of bigger picture.
Experienced managing multiple projects with complex level of detail.
Strong verbal and written communications skills
Experience supporting US, EU MDR, and other global markets.

Nice To Haves

Advanced Degree strongly preferred.
Experience with vision systems, robotics, and connected medical platforms strongly preferred.
Experience with IEC 60601 series and ISO 10993-1 strongly preferred.

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.

Benefits

Relocation assistance may be provided on a case-by-case basis and if approved by the company.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year