Medical Device Reporting Specialist

hace 3 días


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

Genpact is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

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).
  • Manage and coordinate all aspects of medical device reporting within the organization or medical device manufacturing company.
  • Ensure compliance with regulatory requirements and facilitate the timely and accurate reporting of adverse events and product malfunctions associated with medical devices.
Requirements
  • In-depth knowledge of medical device regulations and guidelines.
  • Medical devices complaint handling experience.
  • Familiarity with adverse event reporting requirements and processes.


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