Incident Management Coordinator

hace 2 días


San José, San José, Costa Rica Genpact A tiempo completo

**Company Overview:**

Genpact is a global professional services and solutions firm that delivers outcomes that shape the future. Our team of experts helps leading enterprises, including Fortune Global 500 companies, achieve their goals through our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

The Incident Management Coordinator will play a crucial role in ensuring compliance with regulatory requirements and facilitating the timely and accurate reporting of adverse events and product malfunctions associated with medical devices.

**Responsibilities:**

  • Stay up to date with the latest regulations and guidelines related to medical device reporting, including those issued by regulatory bodies such as the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA).
  • Representatives within the countries that perform the assessment, creation, and submission of Medical Device Reporting.
  • Coordination and execution of the Medical Device Incident reporting handling process.
  • Timely adverse event reporting.
  • Overall responsibility for making Medical Device Reporting decisions.
  • Managing Health Authority Requests.

**Requirements:**

  • In-depth knowledge of medical device regulations and guidelines (e.g., FDA, EMA, ISO 13485).
  • Medical devices complaint handling experience.
  • Experience working with complaint management systems as EtQ and/or Sales Force based software.
  • Familiarity with adverse event reporting requirements and processes.


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