Manager, Regulatory Affairs (Digital Health) - Abiomed

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, Remote (US)

Job Description:

About Cardiovascular

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

Weare searching for the best talent for a Manager, Regulatory Affairs to support Digital Health in our Heart Recovery business.  The preferred location for this role is within a commutable distance of Danvers, MA however remote options within the United States will be considered on a case-by-case basis and if approved by the company.

               

Purpose: The Regulatory Affairs Manager, Digital Health, in partnership with the Director, RA Digital Health and the RA team, will be responsible for developing and executing 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 partner with global teams to inform 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 & Interoperability
• 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

Through your engagement in this role, you will help shape the life-saving field of Heart Recovery.

You will be responsible for:

• 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