Postuler
Motmans & Partners Hasselt

Senior Post Market Specialist EMEA

With a strong background in In Vitro Diagnostics
En ligne depuis 46 jours sur Jobat.be

Senior Post Market Specialist EMEA

Tosoh Corporation is part of a Japanese chemical and specialty products and materials group that comprises over 130 companies worldwide and a multiethnic workforce of more than 12,000 people. Tosoh Europe N.V is a biotechnology-oriented research company which fulfills the role of marketing Tosoh's clinical diagnostic systems and related products such as diagnostic reagents. These self-developed and highly technological instruments are sold and distributed to the medical sector through the various sales agencies across Europe. Tosoh therefore offers a strong customer service and customer support to their customers. From the headquarters in Tessenderlo all customer related activities across the EMEA area are supported and optimized. In light of their further growth and professionalization of the Complaint Handling Process we are looking for a Senior Post Market Specialist EMEA, with a strong background in In Vitro Diagnostics.

Description de la fonction

  • Coordination of the complaint investigation, ensuring customers receive the highest level of service and timely resolution to issues
  • Maintenance and report to management on complaint metrics and trends
  • Coordination of the Risk Analysis into product issues, assuring maintenance of the product risk management file
  • Coordination of the reporting and implementation of the Manufacturer Incident Reports (MIR) and potential Field Safety Corrective Action (FSCA) Reports to applicable regulatory bodies
  • Providing training on the requirements related to Authority reporting, complaint handling process and Post Market Requirements to internal stakeholders
  • Management and coordination of the Product Complaint related CAPAs, change requests, deviations and NCMRs
  • Supporting of the Post-Market Surveillance activities in alignment with regulatory requirements
  • Supporting external agencies and internal audits as needed
  • Carrying out duties in compliance with established business policies
  • Leading and/or contributing to system, product and process improvement projects
  • Report to the Quality Assurance & Regulatory Affairs Manager

Profil

  • Bachelor or Master degree in Science, Biology or Chemistry degree or equivalent
  • 5 years of experience as Post Market Specialist, Complaint Handling Specialist or Regulatory Compliance in a manufacturing environment, preferably in in-vitro diagnostics
  • Excellent English (French, Dutch, and/or German language is an asset)
  • Knowledge and practical application of Quality Management System ISO 13485, ISO 14971 and In-Vitro Diagnostics Regulation (EU) 2017/746? is a plus
  • Knowledge of the Medical or In-vitro Diagnostics Product Technical File structure with focus on customer facing documentation is a plus
  • Experience of using Customer Complaints Systems (e.g CRM) is a plus
  • Advanced critical thinking and investigation skills
  • Willingness to travel 10-15% within EU including Belgium HQ

Offre

  • An exciting position, an international context, an attractive salary package, learning & development opportunities
  • Be part of a great team and a company that strives to reach the highest employee and customer happiness factor
  • Work autonomously and directly contribute to customer satisfaction, and ultimately, business success
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Motmans & Partners Hasselt | Tessenderlo 3980

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    Caractéristiques

    Exigences

    • Bachelor à orientation professionnelle (Enseignement Supérieur de Type Court)
    • Anglais

    Offre

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    • Temps plein

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    • 24 juillet

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