Job Title: Clinical Risk Specialist I

Location: Covington, GA

Contract Term: 5+ Months

Weekly 40.00 Hours [Mon - Fri]

1st Shift

The Clinical Risk Specialist I will perform MDR/adverse event reporting, evaluate clinical use of product, analyze data to reduce occurrence/risk, and analyze adverse events/complaint trends.

This position will ensure that all product complaints are documented, investigated, and reported in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Division, and International policies and procedures.

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 and Excel (Pivot Tables and Charts).

Clinical Risk Specialist I

The Clinical Risk Specialist I will perform MDR/adverse event reporting, evaluate clinical use of product, analyze data to reduce occurrence/risk, and analyze adverse events/complaint trends.

Summary of Position with General Responsibilities

This position will ensure that all product complaints are documented, investigated, and reported in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and

Corporate, Division, and International policies and procedures.

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.

• Coordinate 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.

• Other duties as assigned.

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. Specific vision abilities required by this job include close vision.

Work Environment

This position works in a normal office environment. The noise level in the work environment is quiet to moderate. This position also has exposure to laboratory environment, which may require handling of all types of chemicals including those that present health, flammability, and reactivity hazards. Must be trained in blood-borne pathogens and handling bio-hazardous materials.

Career Level: Experienced