Sorry, this listing is no longer accepting applications. Don’t worry, we have more awesome opportunities and internships for you.

Clinical Complaint Specialist

Marquee Staffing - OS

Clinical Complaint Specialist

Irvine, CA
Full Time
Paid
  • Responsibilities

    Job Description

     

    RESPONSIBILITIES:

    • Responsible for the review, analysis, and summation of medical records and images (e.g., CT) provided in conjunction customer complaints, for inclusion into investigational reports.
    • Participation in the decision making, development, and/or review process related to Medical Device Reporting (MDR) and/or Vigilance or other international reporting.
    • Collaborates with Sales personnel, Customer Service, Engineering, Manufacturing, Quality Assurance, Clinical Affairs, EU Representative, distributors and physician users in these investigations.
    • Supports regulatory body interface related to inquiries associated with adverse event reporting.
    • Provides clinical/medical input regarding classification of hazards and associated risk management activities.
    • Provides clinical and technical assistance and training
    • Interfaces with hospital personnel and physicians involving adverse events.
    • Interfaces with internal and external customers with regard to the clinical impact adverse events. Performs customer site visits, as necessary.
    • Drafts and/or reviews customer results letters related to customer experiences.
    • Provides clinical/medical input for new and revised labeling.
    • Provides clinical/medical input and support to development team in generating risk management activities.
    • Supports internal corporate, notified body, 3rd party, and regulatory agency audits.
    • Prepares reports for periodic management reviews or other purposes.
    • Perform other duties as assigned by supervisor

     

    QUALIFICATIONS:

    Education:

    • Registered Nurse (RN) or other applicable clinical/medical license or degree.

    Experience:

    years of related work experience, including:

    • Minimum of 3 years of medical device experience (Class II/III) or a combination of clinical and medical device experience
    • Prior experience with MDR/Vigilance and other internal regulatory reporting
    • Comprehensive knowledge of quality systems and relationship to business.
    • Ability to facilitate and provide leadership concerning investigational activities.
    • Must demonstrate technical writing ability.
    • Good interpersonal skills including ability to interact with high degree of diplomacy.
    • Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
    • Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
    • Effective problem solving techniques and excellent applied thinking skills.
    • Strong communication and organization skills required.
    • Expertise in Microsoft Office applications and charting programs.