The Clinical Risk Specialist, RN is located at Bard Medical Division in Covington, Georgia.
Summary of Position with General Responsibilities:
The Clinical Risk Specialist will investigate medical device product complaints, perform MDR/adverse event reporting, evaluate clinical use of product, coordinate corrective actions 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 13485 requirements, FDA regulations, and Corporate, Division, and International policies and procedures
Essential Job Functions:
Ensures that all complaints are received, documented, investigated, and trended in accordance with all applicable procedures and regulations.
Ensures that the manufacturing sources are notified of all complaints on products they manufactured and that complaint samples, when received, are forwarded to the manufacturing sources in a timely manner. Review and approve investigations performed by the manufacturing site or OEM Supplier. Work with Manufacturing Sites and OEM Suppliers to ensure corrective actions are documented and monitored to completion.
Assess clinical severity of reported events based on product usage and patient outcome. Will be required to communicate directly with medical professionals or patients regarding reported event.
FDA-MDR and MHRA-Vigilance contact for responding to adverse event inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD.
Review and approve adverse events decision trees in Trackwise (Domestic and International).
Analyze complaints and adverse events and communicate issues and resolutions to management. Generate monthly Adverse Events and Complaint Trending Reports.
Assist project teams with the development of product risk assessment (DFMEA) and clinical severity assessments for new product launches. Transfer risk assessment, predicted occurrence rating, and appropriate defect coding into Field Assurance to ensure proper trending and reporting of complaints following product launch.
Perform complaint handling training with Bard Sales Representatives to ensure all quality defects and adverse events are being reported consistently and in a timely manner to Field Assurance.
Education and/or Experience:
- Excellent oral and written communication skills and telephone presence/manner.
- Detailed oriented -- committed to accuracy, efficiency, and consistency.
- Must be customer focused.
- Detailed oriented – committed to accuracy, efficiency, and consistency.
- Proficient in the use of a personal computer with intermediate level of keyboarding skills.
- Strong interpersonal skills required in the areas of verbal and written communications, customer focus, telephone courtesy, professionalism, and influencing.
- Ability to handle multiple tasks in an organized/efficient manner and maintain good composure in stressful situations.
- Good proofreading skills and memory retention.
- Must be able to comprehend and apply QSR and FDA regulations and follow procedures.
- Must be able to work in a team environment.
Bachelor’s degree in Nursing required. Clinical experience a plus.
Experience with MS Office software (Word, Excel, and Access). Experience with complaint handling databases (Trackwise) or medical record databases a plus.
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 fifteen pounds. Employee is required to meet with other personnel in other areas of the building. Specific vision abilities required by this job include close vision.
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...