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.

Responsibilities:

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 need 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.
• 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

Qualifications:

• 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

Preferred:

• 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

The anticipated base pay range for this position is: $117,000 - $201,250.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401k).This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: 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. For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on October, 29, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Required Skills:

Preferred Skills:
Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility