Regulatory Compliance Specialist

hace 1 semana


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

Genpact, a global professional services and solutions firm, is seeking a skilled Regulatory Compliance Specialist to join our team.

Job Summary

We are looking for an experienced individual to manage and coordinate all aspects of medical device reporting within our organization or with our medical device manufacturing clients. This role will play a crucial part in ensuring compliance with regulatory requirements and facilitating the timely and accurate reporting of adverse events and product malfunctions associated with medical devices.

This position involves:

  • Staying 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).
  • Representing our company in 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.

This role also includes:

  • Managing Health Authority Requests.
  • Responsible for vigilance and adverse event reporting to local Health Authorities ensuring compliance with standards.
  • Worldwide and importer MDR reporting.
  • Adverse Event Reporting: Responsible for assessing complaints to determine reportability in various regions, drafting and submitting Adverse Event (AE), death and malfunction reports in a timely manner as per regulations.

The ideal candidate will have:

  • In-depth knowledge of medical device regulations and guidelines (e.g., FDA, EMA, ISO 13485).
  • Medical devices complaint handling experience.
  • Familiarity with adverse event reporting requirements and processes.
Compensation

The estimated annual salary for this role is approximately $80,000-$100,000 depending on location and experience.



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