> Markdown version of [/jobs/ext/2598410-associate-director-regulatory-affairs-robotics-digital-solutions-medtech-surgery](https://www.wearedevelopers.com/jobs/ext/2598410-associate-director-regulatory-affairs-robotics-digital-solutions-medtech-surgery). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Associate Director, Regulatory Affairs (Robotics & Digital Solutions) - MedTech Surgery - **Company:** Johnson & Johnson - **Location:** Santa Clara, CA, United States - **Experience:** Experienced - **Salary:** $157,000.0 - $271,400.0 - **Contract:** Permanent contract - **Skills:** Cyber Security, Software Engineering, Subsystems, Visual Systems, Meditech - **Published:** August 26, 2026 - **Apply:** http://hbcu.com/cgi-bin/jobs/searchJobs.cgi?job_id=35050533 ## About the Role * 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. * Experience with vision systems, robotics, and connected medical platforms strongly preferred. * Experience with IEC 60601 series and ISO 10993-1 strongly preferred., Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Managing Managers, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking ## Description Job Title: Associate Director, Regulatory Affairs (Robotics & Digital Solutions) - MedTech Surgery, * 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. ## Related Videos - [10M Data Records Lost, Underwater Computing, and Psychedelic Fish - Matthias Geniar](https://www.wearedevelopers.com/videos/1908-10m-data-records-lost-underwater-computing-and-psychedelic-fish-matthias-geniar) - [Thinking Differently - How to Make Money from Cyber Attacks & Cheats](https://www.wearedevelopers.com/videos/745-thinking-differently-how-to-make-money-from-cyber-attacks-cheats) - [Robots are coming into the wild! Full-Stack Robotics Engineers, be ready!](https://www.wearedevelopers.com/videos/479-robots-are-coming-into-the-wild-full-stack-robotics-engineers-be-ready) - [Cyber Security: Small, and Large!](https://www.wearedevelopers.com/videos/259-cyber-security-small-and-large) - [Develop on Windows, Deploy on Red Hat Enterprise Linux](https://www.wearedevelopers.com/videos/1600-develop-on-windows-deploy-on-red-hat-enterprise-linux) - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [How Many Jobs Are Available in Technology?](https://www.wearedevelopers.com/magazine/450-how-many-jobs-are-available-in-technology) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer)