Digital Health Regulatory Affairs Manager

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 Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: We are searching for the best talent for Regulatory Affairs Manager- Digital Health. 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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech #LI-Remote This is a remote role available in all states/cities within the United States While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. The Digital Health Regulatory Affairs Manager will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices. In addition, this role will serve as a liaison for our global regulatory teams as we expand our product approvals across geographies. You will advise on global regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission during the review period. You will support global regulatory teams as an interface with the product development teams in Digital Health. Your core focus will be regulatory leadership for Digital Health across Heart Recovery’s cardio-pulmonary product portfolio: the Impella Ecosystem (Heart Pumps), PreCardia (cardio-renal unloading - decompensated heart failure (ADHF), restoring kidney function) and Breethe (ECMO: respiratory failure) with particular emphasis on: Cybersecurity Software (SiMD and SaMD and AI/ML based clinical decision support) Systems Engineering and liaison with the Clinical/Medical office as needed to establish robust V&V of the product portfolio. Digital Health Policy and Intelligence to ensure that global regulations are considered in product development and design undefinedThrough your engagement in this role, you will help shape the life-saving field of Heart Recovery. The ideal candidate will: Have Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions that include cybersecurity (524B compliance), software and hardware components Have experience with complex networked device ecosystems like Cardiac Electrophysiology, Diabetes, Neuromodulation, Robotic Surgery etc. Experience with SiMD, SaMD required. AI/ML experience preferred. Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices Be energized by joining a world-class company and regulatory team Enjoy teamwork and thrive as a member of dynamic cross-functional teams Build and maintain strong interpersonal relationships within and outside of the company Exhibit leadership traits: positive, forward looking, accountable, action-oriented, delivering results Be adaptable and thrive in a dynamic work environment where variety is the routine Embrace change, continuous learning, and work skills improvement Key Responsibilities: Independently support cross-functional new product development projects with a specific focus on cybersecurity, software (SiMD and SaMD and AI/ML based clinical decision support), and hardware aspects, and lead compilation of all materials required for submissions to FDA Provide ongoing support to project teams for regulatory issues and questions. Find, interpret, and apply global digital health regulations and guidance appropriately for situations Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance Provide support for changes to existing products, including providing regulatory assessment of changes and subsequent regulatory filings Develop solutions to a variety of technical problems. Actively participate in problem solving discussions and recommend solutions Keep abreast of global Digital Health guidance documents and regulations and monitor impact of changing regulations on submission strategies Assist in the maintenance and improvement of digital health regulatory SOPs Interact and negotiate with regulatory agencies on defined matters as needed Required Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions or FDA review experience in Cybersecurity (524B), SiMD and SaMD. Minimum of 6 years Regulatory Affairs experience with a Bachelor's degree or minimum of 5 years Regulatory Affairs experience with an advanced degree History of successful IDE/PMA/510(k) device submissions (Class III device submissions preferred) that include hardware and software components Experience independently communicating with FDA reviewers and leading Q-sub meetings and informal discussions with reviewers Experience supporting software device development (for example SiMD, SaMD, Cybersecurity, IEC 62304/82304 etc) Experience with FDA requirements, guidance documents, ISO 14971, ISO 13485, IEC 60601, IEC 62304, Cybersecurity 524B compliance Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance Ability to effectively manage multiple projects and priorities Strong co