Job Summary

The Manager, Quality Complaints MDR/MDV is responsible for managing the complaint handling process related to the documentation, investigation, timely processing, reporting with emphasis on Medical Device Reports (MDR) and Medical Device Vigilance (MDV).

Duties & Responsibilities

• Manage the day to day complaint handling process with emphasis on MDR and MDV management and related activities:
  • Oversee the investigation and review process related to post-market adverse event reporting for the US, Europe, and other International regulatory bodies;
  • Ensure all required medical device reports are submitted in accordance with the Company's procedures;
  • Lead the development of preliminary health hazard evaluations and reviews, product analyses and failure investigations, as required;
  • Collaborate with clinical team on health hazard evaluations and review of complaints with regard to patient risk and safety assessments;
  • Provide training to internal team members on the Company's complaint handling process, MDR and MDV processes and requirements;
  • Interface with hospital risk management personnel and physicians during the process of conducting investigations for adverse events;
  • Drafts and reviews customer responses and/or responses to global regulatory bodies;
  • Monitor trends in areas of responsibility and escalate issues to management, as needed;
  • Serve as the subject matter expert for MDR and MDV functions during internal and external audits;
  • Ensure that all complaints related to MDR and MDV requiring responses are properly addressed;
  • Administrative activities related to the management of the team responsible for MDRs and MDVs; including timely submissions of MDR and MDVs reports.
  • Oversee the work of assigned team members; coordinate work schedules; assist management in developing standards for acceptable levels of performance within the work group; monitor and report on performance against established standards; report on performance for the purpose of identifying training and development opportunities for staff; make hiring, promotion, demotion and termination decisions; make staff annual performance appraisals and salary increase decisions; provide technical guidance and/or subject matter expertise for staff; approve hours worked and time off requests;
  • Responsible for monthly MDR Review Board and Accuracy meetings.
  • Participate in monthly Post-Market Surveillance meetings and provide data as needed.
  • Perform other duties or special projects as assigned by area management

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

1. 8 or more years of experience processing complaints in medical device industry;
2. Experienced in MedWatch and international adverse event reporting requirements;
3. Experienced in FDA Quality System Regulations- 21 CFR part 820, Part 803 and Part 806 and, Medical Device Directive, EU Medical Devices Regulation and MEDDEV guidance documents, associated harmonized standards, ISO 13485, and related quality standards;
4. Skills required:
5. Strong computer skills
6. Strong organizational and analytical skills
7. Ability to interact effectively on a team and with internal and external customers
8. Demonstrated independent worker with ability to focus
9. Demonstrated attention to detail

Preferred Qualifications

• Clinical experience/background is preferred;
• Previous managerial experience;

Education

Bachelor's Degree is required, preferably within the Sciences or the Clinical field

Compensation: The anticipated range for this position is $125,000 to $160,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

Physical Requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.