Senior Regulatory Affairs Program Lead (OTTAVA) - MedTech Surgery

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

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Remote (US), Santa Clara, California, United States of America

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Senior Regulatory Affairs Program Lead to support our OTTAVA robotics group. Preference will be given to candidates located within a commutable distance of Santa Clara, CA however remote options will be considered on a case-by-case basis and if approved by the company.

Purpose: In joining our growing regulatory team, the Sr. Regulatory Affairs Program Lead will help OTTAVA reach US and international regulatory (NPD) approval goals. Under minimal supervision, the selected candidate will lead regulatory strategy development and execution for the robotic systems portfolio. They will work closely with exceptional engineering and clinical teams, supporting product development stages, generating submission ready documentation, and authoring regulatory submissions. Additionally, this individual will support health authority communications.

You will be responsible for

• Prepare and execute regulatory strategies for NPD and LCM projects.
• Serve as strategic regulatory lead across product development, submission, approval, and LCM activities.
• Serves as a regulatory SME on cross-functional partners with strong knowledge of electromechanical devices with software enabled functionality. Responsibilities include conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, labeling and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission.
• Prepare and submits regulatory information required to obtain timely US market access, including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s). Lead FDA meeting preparation.
• Executes sustaining activities including change assessments, Letter To File, registrations and renewals.