Function
Regulatory Affairs Group
Sub function
Regulatory Affairs
Category
Experienced Analyst, Regulatory Affairs (P5)
Location
Santa Clara / United States of America
Date posted
Jun 10 2025
Requisition number
2506238085W
Work pattern
Fully Remote
This job posting is anticipated to close on Jun 20 2025. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Description
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 https://www.jnj.com

JOB DESCRIPTION:

Johnson & Johnson is hiring for a Sr Regulatory Affairs Specialist, Ads/Promo Global – Shockwave to join our team located in Santa Clara, CA or Remote.
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 https://www.jnj.com/.
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

POSITION OVERVIEW

The Senior Regulatory Affairs Specialist assisting with Advertising and Promotion Regulatory responsibilities, works closely and partners with internal departments to help efficiently and effectively meet assigned regulatory requirements for Shockwave Medical. The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to assist in ensuring that advertising and promotion activities meet regulatory requirements. In alignment with responsible Regulatory Affairs Management, the Senior Regulatory Affairs Specialist (Advertising/Promotion) is responsible for reviewing and approving advertising and promotional material in compliance with internal policies and applicable government laws and regulations. This individual will support decision-making on advertising and promotion regulatory activities.

REQUIREMENTS

• Minimum 5 years’ experience in a regulated healthcare industry with Bachelor’s degree; or 3 years and a Master’s degree; or a PhD with 1 year experience; or equivalent experience. Degree in science, math, engineering, medical or other technical fields and Class II/III medical device experience is preferred.
• Minimum 1-2 years of experience in conducting regulatory affairs reviews of advertising and promotional material in a medical device environment.
• Advanced knowledge of US and international medical device promotion regulations and guidelines.
• Experience with development and/or maintenance of advertising/promotion documents such as a core claims document.
• Ability to work accurately and collaboratively in a fast-paced environment while managing multiple priorities.
• Apply effective communication skills, with the ability to convey messages in a logical and concise manner.
• Ability to consistently reinforce regulatory expectations and requirements.
• Think analytically with good problem-solving skills.
• Effectively negotiate internally and externally with regulatory agencies.
• Clear and effective verbal and written communication skills with diverse audiences and personnel.
• Support and comply with the company’s Quality Management System policies and procedures.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Knowledge of business functions and cross group dependencies/ relationships.
• Ability to follow scientific arguments and identify regulatory scientific data needs.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Must be able to travel for occasional meetings, approximately 1-2 times per year.
• Proficiency in MS Word, Excel and PowerPoint required.

Please refer the Job description for details