Senior Regulatory Affairs Program Lead (OTTAVA)

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. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Information Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional Job Posting Locations: Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America, Remote (US), Santa Clara, California, United States of America Surgery About Surgery. Fueled by innovation at the intersection of biology and technology, we are 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 is 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. We are searching for the best talent for a Senior Regulatory Affairs Program Lead to support our Instrumentation & Accessories team under the OTTAVA robotics group. Preference will be given to candidates located within a commutable distance of Cincinnati, OH, Santa Clara, CA, or Raritan, NJ however remote options will be considered on a case-by-case basis. 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 instruments and accessories 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. Responsibilities Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator. Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals. Prepares and submits regulatory information required to obtain global market access, including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s) and global health authorities’ submissions technical documents. Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams. Conducts reviews and provides expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission. Proactively identifies issues, effectively communicates timelines for project completion, and addresses complex issues that may impact registration status. Conducts regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generates the required regulatory submission (including Letters To File) guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials. Assists in the development of Regulatory Affairs processes. Requires up to 25% travel. Has previous experience with health authority meetings/interactions. Has experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and their documentation in submissions. Qualifications / Requirements Minimum of a Bachelor's Degree required, Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field. Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required (4+ years with Advanced Degree). Experience with medical device regulatory new product submissions required. A demonstrated track record of developing and driving implementation of regulatory strategies. Working knowledge of how global regulations impact product registration. Good communication skills for effective collaboration with cross-functional partners. Corresponding and collaborating with colleagues globally for strategic contribution and achievement of regulatory milestones. Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact. Excellent verbal and written communication skills; strong attention to detail. Advanced analytical and problem-solving skills. High organization skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks. Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion. Required Skills Analytical Reasoning Business Writing Coaching Collaboration Communication Legal Support Problem Solving Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Regulatory Reporting Risk Assessments Strategic Thinking Preferred Skills Analytical Reasoning Business Writing Coaching Collaboration Communication Legal Support Problem Solving Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Regulatory Reporting Risk Assessments Strategic Thinking Pay The anticipated base pay range for this position is : $109,000.00 - $174,800.00. For Bay Area: $125,000.00 - $201,250.00. Benefits Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Vacation –120 hours per calendar year. Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year. Holiday pay, including Floating Holidays –13 days per calendar year. Work, Personal and Family Time - up to 40 hours per calendar year. Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child. Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year. Caregiver Leave – 80 hours in a 52-week rolling period. Volunteer Leave – 32 hours per calendar year. Military Spouse Time-Off – 80 hours per calendar year. For additional general information on Company benefits, please go to: Employer Statement 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 as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource. Privacy Notice Do Not Sell or Share My Personal Information Limit the Use of My Personal Information 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 #J-18808-Ljbffr 6267-Auris Health Inc. Legal Entity