Medical Device Post-Market Surveillance SME (REMOTE)

Charlotte, NC

Industry: Med Job Number: 130706

 

Medical Device Post Market Surveillance SME (REMOTE)

Environment:

Our client is a large medical device manufacturer. They are in need of a Post-Market Surveillance SME to perform Gap Assessments and Remediation of both local and global Post-Market documentation to achieve EU MDR compliance.

Duties/Responsibilities/Scope of Work

This individual will come from a Medical Device background, with extensive experience in Post-Market Surveillance. This consultant will be responsible for performing  Gap Assessments at both the local and global levels, for documentation related to 4 specific areas: 1. Post-Market Surveillance, 2. Post-Market Vigilance, 3. Post-Market Trending, and 4. FSCA (Field Safety Corrective Action).

Additional responsibilities/activities will include:
  • Support development of project charter/compliance roadmap for each area
  • Support development of linkage structure between project workstreams
  • Support mapping of existing process (including IT support/Process and Procedures)
  • Identify proposed solutions to gaps, for roll-up into compliance roadmaps
  • Develop/Map desired outcome for future based on Regulatory Requirements -
    • Initial Key areas of focus are seen to be PMS and Trending (planning and reporting)
  • Develop an understanding of what is required for implementation on a number of levels, including, but not limited to, the following:
    • Reporting plans, structure required
    • Actual report requirements
    • Volume/Frequency of reports
    • Trending is estimated at this point to be based on UDI-DI* (by Product Family)
    • PSUR - is estimated at this point to be based on UDI-DI* also (by Product Family) * given vol of Tech files is .c.300 to date the volume of both Trending and PSURs it is expected will far exceed this volume
    • Reporting requirements for Eudamed – what are the required attributes? 
    • What do we need stabilized/centralized to manage file transfer
    • Reduced reporting timelines (Vigilance)
    • Critical review of existing processes, identifying opportunities for improvement
    • Review of all existing procedures, both global and local, as inputs to the gap assessment
    • Identify deliverables from an IT and process perspective
    • Consider how to present and apply PMS plan and PMCF, with inputs from Clinical, Vigilance and other impacted workstreams
    • Map future process (including IT support & deliverables/Process and Procedures)

Required Experience:
  • Medical Device
  • Post-Market Surveillance 
  • Post-Market Vigilance
  • Post-Market Trending
  • Field Safety Corrective Actions (Recall, Corrections, Removals, etc.)
  • Gap Assessment & Remediation
  • US & Global Regulatory Requirements

Job Type: Contract  

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