Regulatory Compliance Specialist
Smith & Nephew
El Coyol, Provincia de Alajuela, San José, Costa Rica
hace 15 mins

Summary

This position effectively supports the complaint handling process and processes complaints in a uniform and timely manner.

This position will act as the single point of contact between internal and external customers, sales organization, healthcare providers, nurses, patients as well as regulatory bodies, such as US FDA, Canadian Health Canada, German BfArM, UK MHRA, French ANSM, concerning products issues, product information, patient requests and complaints.

Responsibilities :

The person in this role will :

  • Receive first information from markets upon complaint information
  • Evaluate incoming data and enter available data into the Global Complaint Handling Database
  • Communicate with customers and requests necessary complaint information from Complainant and involved parties
  • Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information
  • Communicate results of complaint investigation back to customers and is responsible to review the complaint for completeness and accuracy before closure of the complaint
  • Determine the need for regulatory reporting (Medical Device Reporting, Vigilance Reporting) of Complaints to Regulatory Bodies in US and OUS
  • Run the decision tree for reportability to NCAs and documents decisions on reportability in the system
  • Prepare, generate and submit incident reports (MDR, MDV, etc.) upon adverse events and submits follow-up and final reports to U.
  • S., European and International regulatory bodies

  • Work with local in country RA / QA representatives on determination and filing of foreign incident reports
  • Prepare responses to standard requests from Regulatory Bodies.
  • Under the direction of the Regulatory Compliance Manager, this position manages activities and procedures associated with complaint communication.

    The person in this role will be accountable for setting own work direction and completing work tasks.

    Requirements :

    Education : Bachelors degree or equivalent experience required.

    Experience : 2 or more years experience working in a regulatory compliance role in the medical device industry

    Candidates requiring sponsorship now or in the future will not be considered

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