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 Med Tech, 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.

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Job Function: Quality

Job Sub Function: Customer/Commercial Quality

Job Category: Professional

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

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 Med Tech, 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

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.

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.

• 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 and quality objectives (e.g. timeliness for complaint initiation, reportability assessments, MDR/MDV reporting, and investigation and closure of complaints)
  • Maintain compliance with adverse event reporting determinations against domestic and international regulatory requirements which include but are not limited to the US, EU, Japan, Brazil, Australia, and Canada as it relates to the outcome of complaint investigations.
  • Escalate high risk and unanticipated incidents to management as required.
  • Review and approve complaint investigations within the Quality Management System (QMS) for completeness, which include complaint risk assessments, CAPA escalations, lot history record review (LHR), and device RMA return and investigation summary and conclusions, in an accurate and timely manner ensuring concise and grammatically correct English which is appropriate for regulatory review.
• Oversee daily responsibilities of Complaint Investigation Team
  • Lead, manage, and develop members of the complaint investigation team within Post Market Surveillance
  • Provide guidance on dealing with potentially reportable events or complaints with inadequate information.
  • Ensure complaints are prioritized based on patient, product, and compliance risk.
  • Closely monitor the complaint investigation process to ensure…