Sr. Regulatory Operations Specialist (Remote) - Shockwave

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 Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr Regulatory Operations Specialist – Shockwave Medical to join our team located in Santa Clara, CA or Remote US.

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 Operations Specialist is an individual contributor who will help secure and retain global regulatory approvals for medical devices by archiving, creating, and maintaining specific categories of regulatory documentation and data.

Works closely and partners with Regulatory colleagues and other internal departments to meet assigned deliverables and identify areas of improvement within Regulatory Operations efficiently and effectively.

The function of the Senior Regulatory Affairs Specialist, Operations, includes providing submission publishing/verification support and Regulatory compliance support.  Under direction of responsible Regulatory Affairs Management, works independently with minimal oversight.

Essential Job Functions


* Publisher for worldwide regulatory submissions in compliance with geography-specific regulatory requirements 



* Verify and qualify review of submissions and other responses to regulatory...