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Clinical Risk Specialist

Apply Now Job ID R-335028 Date posted 04/08/2019

Job Description Summary

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

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

Job Description

Essential Job Functions:

  • Determine whether a product malfunction or serious injury 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.
  • Contact for responding to FDA and MHRA inquiries. 
  • Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BD UCC. 
  • Review and approve adverse event decision trees in TrackWise (Domestic and International). Review and approve vigilance/international competent authority reports to authorities.
  • Generate MDR and Supplemental Reports.
  • Assess clinical risk of reported complaints using risk management tools (DFMEA), medical literature, or consultations with medical professionals.
  • Review complaint investigations related to manufacturing, design, or clinical use issues.  Ensure consistency and attention to detail in performing and documenting complaints.
  • 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 device codes.  Where appropriate, assist with Health Hazard Evaluations.
  • Coordinate customer in-servicing and follow-up with Sales Force and Clinical Educators.
  • 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 in nursing required.
  • 3+ years of nursing/clinical experience required.
  • Preferred experience with FDA regulated industry in complaint handling, MDR/adverse event reporting, and performing complaint investigations.
  • 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.


Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email