Post Market Surveillance Manager- Shockwave Medical

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:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

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

Job Description:

Johnson & Johnson is hiring for a Post Market Surveillance Manager - Shockwave Medical to join our team located in Santa Clara, CA.

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 Post Market Surveillance Manager will perform work under minimal supervision to manage the Complaints investigation process of the Post Market Surveillance System, providing oversight and leadership of complaint investigations into serious incidents and non-serious incidents, to ensure timely MDR/MDV reporting, and maintaining compliance to quality objectives and procedures for timely complaint closure.

This position includes managerial responsibility of the complaint investigators and requires frequent use and general knowledge of industry practices, techniques, and standards in compliance with applicable domestic and international Medical Device Post Market Surveillance regulations.

Essential Job Functions


* Management of the assigned aspects of the Complaint Handling Process
+ Ensure compliance of the Complaints System to internal requirements and Domestic and International Regulations.
+ Ensure compliance with assigned complaint metrics an...