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 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.

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.

• Degree in Computer Science/Engineering (preferred) or Science is required
• Advanced degree is 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.
• Minimum of 6 years Regulatory Affairs experience with a Bachelor's degree or minimum of 5 years Regulatory Affairs experience with an advanced degree
• History of successful IDE/PMA/510(k) device submissions (Class III device submissions preferred) that include hardware and software components
• 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

• 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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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.