[Hiring] Digital Health Regulatory Affairs Manager @Johnson & Johnson Innovative Medicine

Role 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.

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:

• Develop strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
• Serve as a liaison for global regulatory teams as we expand product approvals across geographies.
• Advise on global regulatory requirements as a key member of cross-functional teams.
• Prepare and review FDA submissions.
• Interact with and respond to FDA pre-submission during the review period.
• Support global regulatory teams as an interface with product development teams in Digital Health.
• Focus on regulatory leadership for Digital Health across Heart Recovery’s cardio-pulmonary product portfolio.
• Engage in cybersecurity, software (SiMD and SaMD and AI/ML based clinical decision support), and systems engineering.
• Ensure global regulations are considered in product development and design.
• Independently support cross-functional new product development projects.
• Provide ongoing support to project teams for regulatory issues and questions.
• Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance.
• Develop solutions to a variety of technical problems.
• Keep abreast of global Digital Health guidance documents and regulations.
• 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.
• 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.

Requirements

• 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.

Benefits

• Competitive, performance-based compensation programs.
• Annual performance bonus in accordance with the terms of the applicable plan.
• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Participation in the Company’s consolidated retirement plan (pension) and savings plan (401k).
• Eligible for the 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.