PSUR Project Coordinator

Kelly FSP is proud to collaborate with a prestigious client in the medical device sector, and we are currently seeking a passionatePSUR Coordinator, The PSUR Project Coordinator acts as the project management process owner. This role focuses on process optimization and the deployment and utilization of consistent project management methodologies in support of the execution of Periodic Safety Update Reports

Responsibilities

• Knowledge and access to applicable Medical Device Quality Systems to support the teams in document retrieval and routing of documents for approval
  
• Maintain professional and accurate communication with Notified Bodies, including submission of PSURs, responsiveness to Questions/Deficiency Reports, and recurring touchpoints.
• Maintain and execute project management tools and monitors smooth execution of project milestones and task levels as well as overall program process.
• Provides project management and leadership to staff
• Actively partners with cross-functional business partners such as Medical Safety, Scientific Operations, Post Market Surveillance, Design Quality Engineers, Product Development, Clinical Affairs, and Regulatory Affairs relating to the PSUR process

Qualifications

• Bachelors degree in a technical discipline is required; advanced degree is preferred
• Minimum of 3 years of related job experience is required
• Demonstrated knowledge and experience in project management principles and methodologies is required
• Strong written and oral communication skills is required
• Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, Notified Body communication, and Periodic Safety Update Report (PSUR) document creation is preferred

You will join a team of dedicated professionals in a collaborative and innovative environment. Your expertise can make a difference in the lives of many. Join us in shaping the future of medical device development.