Director Regulatory Affairs Digital Solutions

Johnson & Johnson's Family of Companies is recruiting for a Director, Regulatory Affairs Digital Solutions. The preferred location for this position is Cincinnati, OH or Santa Clara, CA. Robotics and Digital Solutions, is part of Johnson & Johnson Med Tech. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara), Cincinnati, and Seattle. You’ll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals’ skills and improves patient outcomes. As a member of Robotics and Digital Solutions Regulatory Affairs Leadership Team, you will engage with new product development teams & regional partners to establish regulatory strategies, participate in creation and review of key product development deliverables and regulatory documents. This position reports to the Vice President of Regulatory Affairs, Robotics and Digital Solutions. Key Responsibilities: Develop global regulatory strategies to gain earliest possible, least burdensome regulatory approval in US and other international markets for new or modified products. Ensures required content for regulatory submissions are defined and oversee the preparation of submissions Develop and manage submission timelines & resources to support regulatory milestones. Member of Digital Solutions Leadership Team, supporting global business strategy, with President as key stakeholder; Sits on RAD RA Leadership Team Build and effectively lead high-performing Regulatory team Monitor and provide management with impact of changes in the Regulatory environment. Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions in coordination with management. Ensures change control documents are reviewed and regulatory impact for external and internal documents are ascertained and rationales to file documentation for modifications to devices are established. Identify gaps in product development plans that may pose regulatory issues and come up with novel development strategies Provide review and approval of all external facing communications advertising and promotional labeling to ensure compliance with corporate policy, US and international laws and regulations Participate in FDA, notified body and other regulatory body inspections. Establish processes and systems to ensure efficient and effective RA operations Qualifications Education Bachelor’s Degree in a scientific or technical discipline. (required) Experience and Skills: Required: Minimum of 7 years of experience in medical device regulatory affairs with specific experience preparing domestic and international regulatory submissions 3-5 years of managerial experience (direct reports) Track record of successfully obtaining market clearance and/or approvals domestic and international Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820. Experience in Q-sub, pre-submission negotiation process Superior written and verbal communication and presentation skills. An approachable individual who provides a high level of teamwork and cross-functional collaboration. Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks. Preferred: Shape and contributes ideas that challenge thinking, proposes, and tries new novel approaches Working knowledge of IEC 60601-series standards, specifically IEC 62304 Prior experience with SaMD, MDDS, AI/ML, non-SaMD, Digital Healthcare Ability to translate and simplify technical content or regulations and communicate to stakeholders An approachable individual who provides a high level of teamwork and cross-functional collaboration. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com. Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Ohio-Cincinnati-4545 Creek Road Other Locations North America-United States-California-Santa Clara Organization Auris Health, Inc. (6267) Job Function Regulatory Affairs Requisition ID 2206027495W