J&J Family of Companies Sr. Mgr. Post Market Surveillance in Redwood City, California
Sr. Mgr. Post Market Surveillance - 2306123212W
The Robotics & Digital Solutions (RAD) group is recruiting for a Senior Manager, 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.
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 Sr. Manager 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.
A minimum of B.S. in Engineering or other physical science
A minimum of Seven (7) years of Medical Device and/or pharmaceutical experience.
A minimum of Five (5) years of management experience.
A minimum of Three (3) years of Complaints, Post-Market and/or Field Action experience.
Knowledge of WW regulatory reporting requirements for Adverse Events
Proven understanding of Risk Management
Outstanding communication, presentation and interpersonal skills working within all levels of the organization.
An approachable individual who provides a high level of partnership and cross- functional collaboration
Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative demeanor.
This role may require up to 10% travel.
This position requires to be onsite a minimum of three (3) times a week.
The anticipated base pay range for this position is $130,200 to $224,825.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com
Primary Location NA-US-California-Redwood City
Organization Auris Health, Inc. (6267)
Travel Yes, 10 % of the Time
Job Function Quality (Eng)
Req ID: 2306123212W
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