The Sr. Field Assurance Manager is located at C. R. Bard Medical division in Covington, GA.
Summary of Position with General Responsibilities:
This position manages the Field Assurance Department from a global perspective and provides a high degree of confidence that all product complaints received on products manufactured and/or marketed by Bard Medical Division (BMD) and any of its business groups are documented and maintained in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Division, and International policies and procedures.
Essential Job Functions:
Establish the systems and processes for receiving and handling complaints.
Establish the systems and processes, including the assessment tools for determining and reporting MDRs.
Establish a process by which complaints in the post market surveillance study are entered in the complaint system.
Coordinates the review, investigation, and corrective actions of product complaints with manufacturing source Quality Assurance personnel to ensure consistency and attention to detail in performing and documenting complaint evaluations.
Interacts with other manufacturers to establish complaint handling, adverse event reporting, and distributor reporting responsibilities.
Interprets corporate policies and regulations as to how they relate to Field Assurance, and prepare and implement Divisional procedures for conformance.
Prepares departmental budget and operates within the budget.
Ensures the accuracy and efficiency of complaint documentation from the initial receipt of a product complaint and opening of a complaint file to the closure of the file.
Manage complaint turnaround times and corrective action follow-up.
Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
FDA-MDR contact for responding to FDA inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD.
MHRA-MDR contact for responding to MHRA inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD.
Ensures that all complaints on products marketed by BMD and any of its associated business groups are received, documented, analyzed, and trended in accordance to Corporate and Divisional policies and procedures, and applicable regulations.
Ensures monthly complaint, adverse event, and recall trending reports are generated and presented to upper management during quality meetings.
Coordinate worldwide exchange of complaint information.
Communicate complaint trends to business franchise teams to ensure that compliance and business requirements are met.
Manage field actions including recalls and field notifications. Complete FDA reporting activities until recall is complete.
Monitor user related complaint trends. Coordinate customer in-servicing and follow-up with Sales Force and Clinical Educators.
Based on customer experience, provide input as needed into the development of sales force training materials.
Functions as Product Litigation Coordinator and interacts with Corporate Legal in responding to litigation requests, reimbursement requests, and evaluation results requests for BMD.
When required, respond to interrogatories, collection of documents and participate in depositions.
Complaint Handling and Reporting Responsibilities
Receive complaints and follow-up to collect relevant information from the user.
Arrange for the return of complaints samples.
Direct the investigation of complaints including any bench testing.
Review existing P/DFMEAs for updates, as required.
Make clinical severity and risk assessments, classify and assign FDA defect code. Where appropriate, arrange for a HHE by a medical professional.
Determine whether a product malfunction or serious injury report needs to be filed with the FDA.
Where a complaint should be an MDR, file the necessary report with the FDA within required time frames.
Evaluate potential MDRs, conduct a risk analysis and obtain a HHE, when necessary.
Where necessary, handle FDA inquires of complaints.
Interacts with international facilities with reporting responsibilities to BMD in establishing standardization of complaint handling and MDR/vigilance compliance.
Approve all International Vigilance decision trees.
Where the complaint should be a Competent Authority Report, create the vigilance report, if required, provide any CA inquiries.
Maintain all required records for the complaints and/or MDR Reports.
Where necessary, assign CAPA investigation.
Train customer facing staff, such as sales staff, on the complaint system and internal reporting procedure.
Lead training on GMPs/complaint handling for sales representatives.
When sales training materials involve questions of safety or indications, review and approve the sales force training materials.
Approve the protocol for any post market surveillance study or evaluation.
Review and approve interim and final reports of a post market surveillance study.
Education and/or Experience:
- 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, service to internal customers, telephone manner, professionalism, coaching, influencing, and team building.
- Strong listening and assessment skills.
- Strong questioning & problem-solving skills.
- Detail oriented, committed to accuracy, efficiency, and consistency.
- Good proofreading skills and memory retention.
- Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
- Must be able to manage people and control stressful situations.
- Must be able to maintain a calm and positive approach to negative issues and resolve day-to-day problems associated with managing the personnel and duties of the Field Assurance Department.
- Must be able to maintain legible, accurate records.
Four-year degree in science or technical field.
Minimum ten years of experience with FDA regulated industry including five years in complaint handling, MDR/adverse event reporting, and complaint investigations.
Minimum five to eight years managerial experience.
Must possess a professional image and demonstrate work maturity.
Minimum eight years experience in Quality Assurance or Regulatory Affairs in a medical device environment.
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.
C. R. Bard - 2 years ago
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