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 Med Tech, 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  () .

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  

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), Pre Cardia (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

+ undefined

Through 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…