Senior Regulatory Affairs Program Lead; Robotics & Digital Solutions - MedTech Surgery

At Johnson & Johnson, we believe health is everything.

Senior Regulatory Affairs Program Lead – Instrumentation & Accessories – Cincinnati, OH (Hybrid/Flex) – will drive regulatory strategy development and execution for robotics and digital solutions, leading global regulatory submissions and collaborating closely with engineering and clinical teams.

• Instill and drive a vibrant regulatory culture, collaborating with cross‑functional teams.
• Apply strategic regulatory thinking to develop and implement regulatory strategies for new product clearances and approvals.
• Prepare and submit global regulatory information, including FDA submissions (Q‑submissions, IDEs, De Novo, 510(k) s) and health‑authority submissions.
• Serve as a Regulatory Affairs subject‑matter expert on new product development and engineering design‑control teams, providing regulatory feedback on specifications, device testing, risk management, and documentation.
• Proactively identify issues, communicate project timelines, and address complex issues impacting registration status.
• Conduct regulatory evaluation of device changes and generate required submissions such as Letters to File.
• Guide conformance with applicable regulations and guidance in product development, claims, labeling, and promotional materials.
• Assist in developing Regulatory Affairs processes.

• Minimum bachelor’s degree; advanced degree highly desired (science, engineering, or related field).
• 6+ years of regulatory affairs experience in medical devices (4+ with an advanced degree).
• Experience with medical‑device regulatory new‑product submissions.
• Demonstrated track record of developing and implementing regulatory strategies.
• Knowledge of how global regulations impact product registration.
• Excellent verbal and written communication, strong attention to detail, and advanced analytical/problem‑solving skills.
• High organization skills and ability to lead multiple projects simultaneously.
• Strong learning and presentation skills for complex regulatory strategies.
• Experience with health‑authority meetings/interactions; experience with software guidance, IEC
  60601, sterilization, biocompatibility, and reprocessing requirements.

Up to 25% travel required.

Pay range: $ - $ (Base).

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities. We are committed to providing an inclusive interview process and accommodations for applicants with disabilities. For accommodation requests, contact  or AskGS.