Regulatory Affairs 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 Regulatory Affairs Specialist (Remote) – Shockwave Medical to join our team located in Santa Clara, CA and 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 Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements.

 Under the direction of the Regulatory Affairs Team, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department, including submission support and maintenance of existing product files, and ensures that deadlines are met.

 

Essential Job Functions
•    Assist with compiling, preparing, reviewing and submitting regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.)
•    Assist with the preparation of OUS product registration(s) documents by working with Authorized Representatives in EU, distributors, and/or Local Responsible Person (LRP)
•    Provide other country specific regulatory support
•    Maintain Regulatory shipping authorization docume...