Digital Health Regulatory Affairs Manager

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

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.

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