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Complaints Handler
Complaints HandlerHireTalent - Staffing & Recruiting Firm • Lafayette, CO, US
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Complaints Handler

Complaints Handler

HireTalent - Staffing & Recruiting Firm • Lafayette, CO, US
Hace 6 días
Tipo de contrato
  • Temporal
Descripción del trabajo

Title - Complaint Handling Specialist

Location - Lafayette, CO, 80026

Duration - 12 months contract

Payrate - $30 / hour on W2

Job Description -

Must Have :

  • Bachelors degree required

Nice to Have :

  • 1+ years of experience in Complaint handling or customer service / technical support experience
  • 6+ months experience in safety or clinical data evaluation
  • 6 + months of experience in a medical device company or healthcare / pharmaceutical industry
  • Ability to work independently or in a team setting
  • Degree in Health Care, Sciences, or Bio-Medical Engineering
  • Strong attention to detail
  • Excellent communication skills (oral and written), with strong organizational and analytical skills
  • Knowledge of basic anatomy, physiology, and medical terminology
  • Strong analytical skills (problem solving, critical thinking)

    • JOB DESCRIPTION

    Top 3 technical skills that are required for the role :

  • Critical Thinking and Analytical Skills
  • Attention to Detail and Documentation Skills
  • Communication and collaboration

    • Education Required : 4 year degree

    Years' Experience Required : 0-1 year

    Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours a week

    Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? On site (at least 4 times a week)

    What is your timeline for scheduling interviews? In 1-2 weeks

    What product line will this person support? Surgical

  • Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.
  • Writes investigation summaries based on technical product analysis information provided
  • Ensures record documentation is maintained in a constant state of audit readiness per internal policies.
  • Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety, and effectiveness of medical devices.
  • Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.

    • Responsibilities may include the following and other duties may be assigned.

    Processes complaints in the Global Complaint Handling System, supporting the Respiratory Interventions (RI) Operating Unit, according to company policies and regulatory requirements. This may include complaint intake activities, making regulatory decisions, submitting regulatory reports to competent authorities, and providing letters to customers.

    Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.

    Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.

    Act as liaison with various internal and external complaint handling partners to ensure timely and accurate processing of complaints.

    Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

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    Complaint • Lafayette, CO, US