Insulet Corporation

  • Post Market Surveillance Specialist

    Job Locations FR-France | FR-France
    Posted Date 3 months ago(9/3/2018 10:43 AM)
    Category
    Quality Assurance / Quality Engineering
  • Position Summary

    The Post Market Surveillance Specialist position is accountable for ensuring the EU Post Market Surveillance (PMS) process is maintained in full compliance.  This involves thorough investigation of complaints and a close working relationship with the EU Authorised Representatives to support the timely submission of vigilance reports to the relevant EU Competent Authority.  The role encompasses the training of base level complaint and vigilance content for sales teams and in-depth training for Support providers. The position also plays a major role in supporting meetings with in-country Product Support Providers and with the Competent Authorities. The position requires system level comprehension, attention to detail, organisation, and constant interaction within the business to the accomplishment of the company goals.

    Depending on the position applied for, this role will be based out of the Insulet office in Paris, France.

    Responsibilities

    • Establish working relationships with:
      • EU Authorised Representative.
      • In-country Product Support Providers.
      • Full service Distributors.
      • EU Call Centre.
    • Attend/support meetings with the EU Competent Authorities.
    • Maintain the EU Vigilance Mailbox & Tracker (Database).
    • Perform data analysis in support of Vigilance reporting, to include but not limited to:
      • Complaints.
      • Lot release.
      • DHR.
      • basic product review and failure analysis.
      • Reporting and trending.
      • Document review.
      • Reporting and trending.
    • Vigilance reporting (Compiling and submitting).
    • Post Market Surveillance (i.e. Complaint handling, Incident (Adverse Event) Reporting and EU Vigilance Process) – training presentations to internal and external stakeholders.
    • Requests for Additional Information.
    • Record generation and retention.
    • Train others on the requirements of Complaint Coordination activities, including follow-up with the Customer Care Group.
    • Performs other duties as required.

    Education and Experience

    Minimum Requirements:

    • Degree level

     

    Preferred Skills and Competencies:       

    • Minimum of 3-5 years’ experience in Regulatory Affairs and Post Market Surveillance and a sound background in data management, record keeping, and trouble shooting in the Medical Device field, or other transferable experience related to organization, technical aptitude and data management.           
    • Willingness to pursue additional learning and build professional qualifications as required.
    • Ability to demonstrate system level expertise of databases with the ability to train on these identified systems.
    • Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization.
    • Ability to organize and prioritise tasks
    • Excel in generating and maintaining organised and accurate records; PC skill, word processing, spreadsheet, database.
    • Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed