Complaint Specialist II- 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 Complaint Specialist II - 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
In compliance with FDA, European MDD/MDR & other International Regulations, the Complaints Specialist II will perform work under general management supervision. General scope of this position is to ensure compliance to the Complaints and Post Market Surveillance System with the responsibility of timely complaint initiation and assessment of regulatory geography reporting, complaint follow-up, coordination of complaint device returns, and collaboration with the cross-functional engineers and technicians for timely completion of the complaint investigation. The Complaints Specialist II will also be responsible for filing MDR/MDV reports to applicable geography regulatory authorities, maintaining quality compliance, and ensuring quality metrics are achieved. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions

• Under guidance, ensure compliance of the Complaints System to internal requirements and Domestic and International Regulations.
• Initiate complaints and ensure all required information are gathered and added to the complaint file in an accurate and timely manner.
• Communicate with Customers and Shockwave Medical field reps in a timely and professional manner to gather necessary complaint information
• Coordinate the return of complaint devices for investigation (where applicable), and collaborate with the cross-functional engineers to ensure timely investigation and risk assessment of each complaint.
• Complete adverse event reporting determinations per geography regulatory requirements for approved devices (FDA, EU MDD/MDR, PMDA, TGA etc.) and route for approval in a timely manner.
• Escalate high risk incidents to management.
• Complete MDR/ MDV reports in an accurate and timely manner and ensure they are submitted to the regulatory authorities within the required timeframe per applicable geography regulation.
• Ensure compliance to the Post Market Surveillance System and prepare annual Periodic Safety Update Reports, PMS Reports, and other PMS Documents per geography regulatory requirements.
• Tracks regulatory changes in various geographies and update procedures accordingly
• Provide support of technical evaluations and investigational tasks to ensure complaints are investigated and closed in a timely manner.
• Write up complaint investigations using concise and grammatically correct English which is appropriate for regulatory review.
• Support service & repair events including evaluation of inta