Post Market Surveillance Coordinator

NyonTemporaireChimie, Pharma, Biotechnologie2019-04-16Bachelor / Collège / Diplôme
We are recruiting on a temporary contract a

Post Market Surveillance Coordinator

Your Challenge

  • Evaluates incoming complaint information and maintains the records in the electronic database as per company procedures and processes. Works closely with Customer Service to support the product return process as it relates to complaints.
  • Processes, records and closes complaint-handling activities in a timely manner.
  • Conducts follow-up investigations with internal resources, field personnel and/or customer as appropriate to gather additional information for reported events and assist in data collection for trending purposes.
  • Determines reportability of complaints per regulatory reporting requirements
  • Collect, trend and escalate data related to Post Market Surveillance
  • Acts as an interface between EMEIA customer support team, Regulatory Post Market Surveillance team in US and European customers, including distributors;
  • Evaluates and reports device malfunctions and adverse events involving company products to the European regulatory agencies

Your Profile

  • A Bachelor's degree or Swiss CFC (Health sciences preferred)
  • 2 years of experience in Post Market Surveillance department in a regulated environment (e.g. Medical Device, Pharma, Aviation, etc.)
  • US FDA 21 CFR 803/806/820 and EU Medical Device Regulation (2017/745/EU) basic knowledge would be a plus
  • Good knowledge / understanding of the European Medical Device Directive 93/43/EEC and MEDDEV 2.12-1
  • Good understanding of quality records requirements and how they apply to complaint files and post market surveillance reports
  • General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
  • Experience with softwares such as TrackWise, ERP / CRM (eg. SAP) or Salesforce is a plus
  • Fluent (C1 minimum) in written and spoken English
  • Ideally possessing other third language skills for the European market

Votre contact

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La référence de cette offre est JN -042019-295646