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PMS Specialist - French and English speaking - Oustanding reputation C - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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PMS Specialist - French and English speaking - Oustanding reputation C

Nr ref.: /JOBS.pl

  • Key Responsibilities
    Supporting the complaint handling process including:
    ? Document and coordinate the investigation of product performance issues
    ? Coordinate and/or perform complaint investigation, ensure related follow-up activities and document investigation findings and results
    ? Follow up on outstanding evaluations to ensure timeliness and regulatory compliance.
    ? Monitor customer complaints and provide immediate feedback to concerned personnel when critical issue is detected.
    ? Maintain complaint tracking system
    ? Attend/facilitate meetings to resolve Customer Complaints
    ? Ensure effective CAPA is taken to help prevent reoccurrence

    Supporting the Field Action process including:
    ? Ensuring appropriate recall activities are documented, approved and communicated to relevant parties
    ? Preparation and obtaining approval of Field Safety Notices, Field Safety Corrective Action Forms in conjunction with the Coordinating Competent Authorities along with Management.
    ? Collaboration with appropriate personnel to translate the field correction communication and issue of same to Regulatory Authorities with their regions along with consignees.
    ? Coordination of the final disposition of any returned affected product
    ? Compilation and Archiving of all records' associated with the Field Action activity
    • Provide support for the risk management process and provision of complaint data to risk management groups.

    Essential Skills / Experience
    • Engineering/Science qualification with 2/3 years of working within complaints in a medical device environment.
    • Fluency in French language essential
    • 2/3 years experience in vigilance reporting - essential
    • Excellent technical writing experience within a medical device environment - essential
    • Good working knowledge of the Quality System Regulations as they pertain to customer complaints.
    • Problem solving skills for developing creative solutions and meeting objectives are required.
    • Excellent analytical ability
    • The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management. #

    For more information, please contact Marine Dollat at :


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