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Post Market Surveillance Project Manager
Job Opportunity at
Coyote Technical Executive Sourcing, LLC
Posted on Aug 2
POST MARKET SURVEILLANCE PROJECT MANAGER
The PMS Project Manager has responsibility for assuring compliance with national and international regulations with reference to PMS at assigned sites.
Responsible for identifying the requirements for, and the development, establishment and training of post market surveillance at assigned sites based on current applicable standards and regulations.
Works independently to contribute to, monitor and/or oversee various elements of the Post Market Surveillance process.
This may include, but is not limited to PMS Reports, PMS Reviews, PMS Plans, PMS Schedule, PMS Statements & PMS Trend Reviews.
Works independently to contribute to, monitor and/or oversee various projects chartered by the Clinical, Scientific & Medical Affairs department
Oversees development and maintenance of IT systems to support the PMS process
Support responding to requests from competent authorities, registries, and notified body.
Responsible for regular and timely communication of relevant post market data/trends to key employees throughout the organization.
Maintenance of local PMS procedure and forms. Support global PMS procedures and forms.
EDUCATION and/or EXPERIENCE
Bachelor degree in a science, medical or engineering discipline required. Master's or Doctorate degree is desirable.
Five years of experience in the field of PMS or Quality Systems is required.
Experience within the medical device industry and Project Management experience are preferred.
Equivalent years of graduate level education are acceptable in lieu of work experience.
No sponsorship visa (H1-B, etc.) candidates at this time, sorry.
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