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

Johnson & Johnson Innovative Medicine • Santa Clara, CA

7d • $157,000 - $271,400 • Hybrid

About The Position

We are searching for the best talent for an Associate Director, Regulatory Affairs to support our Robotics & Digital Solutions group. This role will work a Flex/Hybrid schedule with 3 days per week on-site and must be located in Santa Clara, CA. Relocation assistance may be provided on a case-by-case basis and if approved by the company.

Requirements

• Minimum of a Bachelor’s degree is required; Advanced Degree strongly preferred.
• 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

• 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager