A Day in the Life
Accomplish results through the management of Complaint Handling team in executing the Complaint Handling processes, including the following:
- Responsible for assisting in the development and implementation of MDR and Vigilance Compliance objectives and strategic initiatives
- Serve as the manager of an MDR/complaint handling team and actively contribute to talent acquisition and talent management for the department
- Responsible for overseeing and managing complete and accurate maintenance and reporting of MDR’s as required by applicable regulatory agencies, standards and guidelines.
- Ensure high level of quality and consistency in event decision evaluation and reportablity of complaints.
- Responsible for overseeing and managing activities related to complaint investigations and follow-up.
- Maintain current knowledge on regulatory worldwide requirements for adverse event reporting.
- Interpret regulations for execution and recommend modification to operational procedures to ensure continued compliance
- Function as a key advisor to assess and make recommendations to ensure continued FDA and Vigilance Compliance for complaints for the Medtronic PXM organization
- Ensure projects are resourced with appropriate level of talent and expertise to ensure successful execution.
- Develop and maintain effective, positive and mutually rewarding relationships with internal and external key stakeholders. Communicate to appropriate stakeholders in a timely manner and implement feedback to ensure needs are met.
- Collaborate with business partners to ensure timely literature searches, timely transfer of clinical data for MDR reporting and exchange for information for annual reports.
- Provide training, coaching and mentoring to MDR and Vigilance Operations leadership and team members to optimize performance
- Participate in the Annual Operating Plan (AOP for the department cost center). Develops and administers budgets, schedules, and performance standards.
- Create a positive and collaborative work environment to ensure MDR and Vigilance complaint handling regulation expectations are achieved.
- Identifies and leads department initiatives that result in resolution of MDR opportunities to increase operational efficiency, quality and cost effectiveness for the MDR department to ensure best industry standards to become a world class complaint handling department
- Identify and participate in continued process improvement of the MDR reporting process, including periodic audit and assessment of the function.
- Collaborate with the global complaint handling group to provide appropriate input for the MDR/Global Vigilance process.
- Support the preparation of adhoc adverse event reports for internal use, reporting to regulatory agencies and answering business partner queries.
- Ensure the quality/system is planned, understood, implemented and maintained by ensuring compliance within the MDR/Vigilance Department.
- Ensure departmental compliance as well as appropriate departmental resources are available to effectively maintain the MDR/complaint handling aspects of the quality system (people, facilities, tools, training)
- Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
- Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs) or adverse reaction data as required by regulatory agencies.
- Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
Must Have: Minimum Requirements
Bachelor's degree with 7+ years of quality, MDR, or regulated experience including 5+ years of managerial experience OR Master's degree with 7+ years of quality, MDR, or regulated experience including 5+ years of managerial experience
Nice to Have
- Experience interpreting FDA regulations for 803 and 806, QSR, and ISO Standards.
- Experience interfacing directly with FDA contacts.
- Bachelor’s degree in health care or bioscience field
- Master’s in Science in Business Administration or Regulatory Affairs
- 5+ years of experience in leading complaint teams and adverse event reporting and/or regulatory affairs for medical devices and/or pharmaceuticals.
- Demonstrated track record of developing talent and managing people to reach their full potential
- Exceptional knowledge and interpretation of MDR/complaint handling regulations
- Knowledge of Cardio Vascular products.
- Experience in leading and managing FDA inspections and responses
- Experience in directly responding to FDA inspectors for MDR process
- Demonstrated leadership and change management ability
- Process improvement mind-set
- Demonstrated team building and engagement results
- Demonstrated strong analytical skills and appropriate use of clinical judgment
- Excellent communication (written and verbal) skills
- Experience in presenting to senior leadership
- Demonstrated ability to develop and implement metrics and quality expectations
- Proficiency in Microsoft Windows, Excel, Power Point and Excel.
- Demonstrated ability to multi-task and prioritize in a fast-paced evolving environment