Clinical Risk Specialist I

Essential Job Functions

• Determine whether a product malfunction, serious injury, or death report needs to be filed with the FDA. Determine whether a 30 Day or 5 Day MDR report is required. Write and/or approve MDRs submitted.
• Review and approve adverse event decision trees (Domestic and International).
• Approve vigilance/international competent authority report to authorities.
• Assess clinical risk of reported complaints using risk management tools (DFMEA), medical literature, or consultations with medical professionals.
• Review complaint and quality investigations related to manufacturing, design or clinical use issues. Ensure consistency and attention to detail in complaint investigations.
• Analyze complaints and adverse events and communicate issues and resolutions to management.
• Receive complaints and follow-up to collect relevant information from the user.
• Make clinical severity and risk assessments, classify and assign FDA/IMDRF device and patient codes. Where appropriate, arrange for HHE by a medical professional.
• Cook up customer in-servicing and follow-up with Sales Force and Clinical Educators.
• Research and identify a U. S. equivalent or similar device of international products for MDR reporting.

Basic Qualifications

• Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
• Ability to effectively manage time.
• Ability to handle multiple task assignments.
• Ability to translate quality requirements into product specifications.
• Ability to interpret Regulations, Corporate, Division and Department procedures.
• Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.
• Knowledge of quality systems and relationship to business.

Education and/or Experience

• Bachelor’s degree required. Nursing degree combined with three years of nursing/clinical experience.
• PREFERRED: Experience with FDA regulated industry in complaint handling and MDR/adverse event reporting.
• Experience with Microsoft Office.
• PREFERRED: Experience in complaint handling software (Trackwise or equivalent), Access Databases, and Excel (Pivot Tables and Charts).

Physical Demands

• While performing the duties of this job, the employee is regularly required to sit and talk or hear.
• The employee is frequently required to use hands to finger, handle or feel.
• The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to ten pounds.
• Employee is required to meet with other personnel in other areas of building.

Career Level

Career Level: Experienced