Digital Health Regulatory Affairs Manager

Johnson & Johnson • Cherry Hill, NJ

4d • Remote

About The Position

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.

Requirements

• Minimum of 6 years’ Regulatory Affairs experience with a Bachelor's degree or minimum of 5 years Regulatory Affairs experience with an advanced degree.
• Degree in Computer Science/Engineering (preferred) or Science is 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.
• 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 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.

Nice To Haves

• Degree in Engineering preferred.
• Ability to comprehend principles of engineering, physiology and medical device use.
• Class III cardiovascular device experience.
• FDA review experience OR Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• AI/ML and/or PCCP experience is a plus.
• History of successful IDE/PMA/510(k) device submissions (Class III device submissions preferred) that include hardware and software components.

Responsibilities

• Developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
• Serving as a liaison for global regulatory teams as product approvals expand across geographies.
• Advising on global regulatory requirements as a key member of cross-functional teams.
• Preparing and reviewing FDA submissions.
• Interacting with and responding to FDA pre-submission during the review period.
• Supporting global regulatory teams as an interface with the product development teams in Digital Health.
• Providing 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 need to establish robust V&V of the product portfolio, and Digital Health Policy and Intelligence to ensure that global regulations are considered in product development and design.
• Independently supporting 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 leading compilation of all materials required for submissions to FDA.
• Providing ongoing support to project teams for regulatory issues and questions.
• Finding, interpreting, and applying global digital health regulations and guidance appropriately for situations.
• Providing regulatory support for currently marketed products as necessary to ensure ongoing compliance.
• Providing support for changes to existing products, including providing regulatory assessment of changes and subsequent regulatory filings.
• Developing solutions to a variety of technical problems.
• Actively participating in problem solving discussions and recommending solutions.
• Keeping abreast of global Digital Health guidance documents and regulations and monitoring the impact of changing regulations on submission strategies.
• Assisting in the maintenance and improvement of digital health regulatory SOPs.
• Interacting and negotiating with regulatory agencies on defined matters as needed.

Benefits

• medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Company’s consolidated retirement plan (pension) and savings plan (401k).
• Company’s long-term incentive program.
• Vacation – up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays – up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager