Manager, Regulatory Affairs (Digital Health) - Abiomed

Johnson & Johnson Innovative Medicine•Danvers, MA

8d•Remote

About The Position

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. 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.

Requirements

Minimum of a Bachelor’s Degree is required, Advanced degree strongly preferred; Computer Science/Engineering discipline highly desired.
At least 6+ years Regulatory Affairs experience (5+ with Advanced Degree) in the medical device space is required; experience with complex networked device ecosystems like Cardiac Electrophysiology, Diabetes, Neuromodulation, Robotic Surgery etc. strongly preferred.
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 required.
History of successful IDE/PMA/510(k) device submissions (Class III device submissions preferred) that include hardware and software components required.
Experience independently communicating with FDA reviewers and leading Q-sub meetings and informal discussions with reviewers required.
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, interoperability.
Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.
Ability to effectively manage multiple projects and priorities.
Strong communication and regulatory writing skills.
Strong problem-solving skills, interpersonal skills, and effective team member.
Results oriented.
Ability to drive to completion in adherence to aggressive project schedules.
Ability to comprehend principles of engineering, physiology and medical device use.
Class III cardiovascular device experience strongly preferred.
Regulatory Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) preferred.
AI/ML and/or PCCP experience is a plus.
Travel up to 10%

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.
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 .
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.

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)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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 period10 days
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: - https://www.careers.jnj.com/employee-benefits