Senior Regulatory Affairs Program Lead

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

Job Function

Job Function: Regulatory Affairs Group

Job Sub Function

Job Sub Function: Regulatory Affairs

Job Category

Job Category: Professional

All Job Posting Locations

Irvine, California, United States of America, Remote (US)

Job Description

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, were 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 thats 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

We are searching for the best talent for a Senior Regulatory Affairs Program Lead . This is a remote role available in all states 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.

Purpose: Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.

Your responsibilities :

• Ensures compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management.
• Instills and drive a regulatory culture. Establish and support policies and standards for the measurement of new products.
• Represents the regulatory function on project teams as a subject matter expert to provide guidance on regulatory requirements and develop worldwide regulatory strategies.
• Coaches project teams on input for product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process.
• Works collaboratively with cross functional teams to resolve complex regulatory issues.
• Develops IDE, 510K, and/or PMA submissions and EU Technical Document for medical devices for commercialization in the USA.
• Generates documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by BWI and/or J&J affiliates.
• Conducts submission negotiations with regulatory authorities as needed throughout the product lifecycle to ensure timely approvals for new products and product modifications.
• Works with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.
• Maintains proficiency on regulatory requirements and develop and maintain rapport with FDA reviewers, project team members.
• Provides continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.
• Performs Copy Review for internal and external facing documentation to ensure compliance with applicable Federal, State, local and Company regulations, policies, and procedures.
• Provides regulatory support for internal and external regulatory agency audits.
• Coaches junior colleagues in techniques, processes, and responsibilities.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications/Requirements :

• Minimum of a Bachelors degree required, Advanced Degree strongly preferred.
• At least 6+ years of relevant experience in the medical device industry with at least four (4) years in Regulatory Affairs of Medical Devices.
• Class III PMA experience is preferred.
• Experience in the cardiovascular/cardiology field preferred.
• Regulatory experience with devices containing software preferred.
• Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations, Worldwide Regulatory Requirements/Procedures, Project Management, and Negotiations.
• Strong understanding of Medical Device regulations / standards and Quality principles.
• Must be able to communicate effectively in a professional environment.
• Must be able to influence without authority.
• Ability to make difficult and often unpopular decisions.
• Ability to manage multiple priorities effectively.
• Strong interpersonal and organizational and problem-solving skills.
• Travel: Up to 10% both domestic and international.

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 and 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 email the Employee Health Support Center (ra-employeehealthsup@) or contact AskGS to be directed to your accommodation resource.

#LI-Remote

The anticipated base pay range for this position is :

The base pay range for this position is $105,000 to $169,050.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay, including Floating Holidays 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below.

Remote: Yes