Regulatory Affairs Program Lead

Johnson & Johnson Medical Device is recruiting for a Regulatory Affairs Program Lead located in Cincinnati, OH. The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services Key Responsibilities: Work closely with engineering and clinical teams, supporting the instrumentation team for the robotic system through product development stages to generate submission ready documentation and author regulatory submissions in order to reach US and international regulatory approval goals. Prepare, submit, and manage regulatory submissions required for device approvals and registrations. Develop and execute regulatory strategies that align with business goals. Function as a Regulatory Affairs subject matter expert on design control teams in accordance with regulatory requirements and with positioning for regulatory submission. Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status. Assist the preparation of instructions for use in collaboration with cross-functional teams. Prepare documentation and reports after interpretation of federal, state, and/or international regulations for submission to other units of the company, customers, governmental regulatory agencies, etc. Additionally, support labelling review, design changes, and post market agency reporting activities. Qualifications Employer will accept Bachelor’s degree in science, or engineering, or other relevant fields followed by six years of progressive, post-baccalaureate work experience in job offered or six years of progressive, post-baccalaureate work experience in a related occupation. Position requires: Experience with preparation, submission, and management of regulatory submissions for medical devices. Experience with Generator G11, Enseal, Harmonic, and Echelon devices. Experience with regulatory project management of multiple medical devices portfolios. Experience with IEC 60601 and medical device software. Experience with US, Canada, Japan or other international medical device regulations and guidance. Experience with regulatory evaluation of changes to electromechanical and software driven medical devices. Experience with being the regulatory affairs subject matter expert on design control, or other cross-functional, teams. Experience with providing regulatory expertise on labeling material reviews using EOS. Experience with regulated environment in compliance to ISO 13485 and using Adaptiv, Agile, or Truvault PLM systems. Experience with engaging with regulatory agencies regarding regulatory submissions, recall activity, post-market commitments, or remediation efforts. Experience with risk management and clinical evaluation in accordance with regulatory requirements. Experience with developing regulatory affairs information database and regulatory controls in JDE or SAP systems. Experience with supporting and improving MDSAP ISO 13485 quality system audits. Experience in complex process improvement/ time-to-market/ policy-shaping/ internal innovation/ data management initiatives, or acquisition/divestitures. 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. 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. 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 Primary Location United States-Ohio-Cincinnati-4545 Creek Road Organization Medical Device Business Services, Inc (6029) Job Function Regulatory Affairs Requisition ID 2206058842W