Director, Post Market Surveillance

The Robotics & Digital Solutions (RAD) group is recruiting for a Director, Post Market Surveillance, located in Redwood City or Santa Clara, CA.

Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

RAD is a technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, RAD is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures.

Overview:

The successful candidate will have responsibility for the overall management of complaints and adverse event reporting activities related to medical or other devices manufactured and/or distributed by RAD. They will assess serious injuries, and device malfunctions in support of regulatory agency product surveillance reporting and ensure that product safety and performance analyses are data driven and scientifically sound.

The Director of Post-Market Surveillance coordinates the escalation process for potential product safety and performance issues and communicates them to management and appropriate individuals. Responsibilities include the collaborative evaluation of product risk and potential safety issues, health hazard analyses and coordination of field actions communication to both customers and regulatory agencies.

This position reports to the Sr. Director of Quality and Compliance.

Core Job Responsibilities:

·       Overall management and compliance of complaints handling, investigations, and adverse event reporting processes.

·       Oversight of the evaluation of potential product issue escalations.

·       Ensuring that complaints and post market data are track and trended and communicated in an effective manner.

·       Establishes data review forums to enable management decisions and optimize customer experience.

·       Coordinates cross-functionally to ensure any field corrections/ actions and or advisory notifications are classified, implemented, and both appropriate customer and regulatory agency communications and have been made.

·       Develops Post Market Surveillance (PMS) Plans and writing PMS reports.

·       Manages and mentors team members in the best methodologies, continuous improvements initiatives.

·       Coordinates with international teams for clinical trial processes and procedures

·       Supports external and internal audits.