Regulatory Compliance Representative 1 (Temporary 6 months)
Smith+Nephew
CR - Alajuela, Coyol
hace 1 día

Role Overview

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 organizations, HCPs, 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.

The person receives first information from markets upon complaint information, evaluates incoming data and enters available data into the Global Complaint Handling Database.

Communicates 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.

Communicates results of complaint investigation back to customers and is responsible to review the complaint for completeness and accuracy before closure of the complaint.

The person is determining the need for regulatory reporting (Medical Device Reporting, Vigilance Reporting) of Complaints to Regulatory Bodies in US and OUS.

Runs the decision tree for reportability to NCAs and documents decisions on reportability in the system. It prepares, generates and submits incident reports (MDR, MDV, etc.

upon adverse events and submits follow-up and final reports to , European and International regulatory bodies. Works with local in-country RA / QA representatives on the determination and filing of foreign incident reports.

Prepares 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.

It is accountable for setting its own work direction and completing work tasks.

Responsibilities

Receives, reviews and enters product complaint information into the complaint handling database.

Interact with HCPs, Patients and the Sales organization regarding their Product Quality concerns. (50%)

Continuously monitors the information gathering process and tracks the status of complaint communication until end customer communication.

Continually track open, in process and complete complaints and product investigations and follow-up internally and externally (20%)

Evaluate complaints to determine whether an adverse event report / Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting (93 / 42 / EEC) and any other worldwide regulatory requirements.

Runs decision trees for reportability in the system and documents review

Ensures that incident reports to , European and International NCAs are submitted within the regulatory timeframes.Documents rationale if incident reports are not required.

Prepares, generates and submits incident reports (MDR, MDV, etc.) upon adverse events and submits follow-up and final reports to , European and International NCAs

Works with local RA / QA representatives on determination and filing of foreign incident reports.

Document and maintain records of all adverse events reporting's in accordance with international laws

Complete all required customer complaint / adverse event related documentation in an accurate, professional and timely manner. (25%)

Prepares responses to standard from Regulatory Agencies (5%)

Education Requirements

Bachelor degree in : Nursing Biology or Microbiology Electromedicine Engineering (Biomedicine Engineering) Engineering : Industrial, Mechanical, or another related discipline.

Licenses / Certifications

RAPS (RAC) or QSA certification (beneficial)

Minimum Experience

  • Regulatory knowledge with complaint handling; adverse event reports; recalls andquality systems (beneficial).
  • Call center experience (beneficial)
  • Competencies

    Strong critical thinking, communication, and problem-solving skills

    Detail Oriented

    Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors

    Must have ability to work in a team environment and be self-motivated and organized.

    Must be fluent in English language, verbal and written.

    Knowledge of Food and Drug Administration, European Medical Device Directive (MDD) and International Medical Device Regulations and quality system regulations (including 21 CFR 803 & 820, 93 / 42 / EEC and ISO 13485 (beneficial)

    Must possess excellent verbal and written communication skills.

    Additional language such as German, French, Italian, Chinese or Japanese beneficial

    Ability to work independently.

    Ability to work in an international environment.

    Strong feeling for Accountability.

    Experience with utilization of Pilgrim, Track Wise or ETQ preferred,

    Must have very good understanding of Microsoft Office applications

    Ability to work with a diverse network of both internal and external groups and / or individuals.

    Strong interpersonal and communication skills, both written and verbal.

    Must be motivated and able to manage multiple projects with key deadlines.

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