Careers that Change Lives
In this exciting role you will have responsibility for managing processes, analytics and staff that work within the complaint handling and medical device reporting (MDR) process on the Product Experience Management (PXM) team. This position is responsible for the identification, leading and coordinating cross-functional activities representing the PXM organization to ensure regulatory compliance, increased quality, efficiencies and collaboration with key stakeholders and internal business partners. Medtronic seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Identifies and leads department initiatives that result in resolution of PXM opportunities to increase operational efficiency, quality, consistency, compliance and cost effectiveness.
- Provide direction for PXM for the Complaint Registration process.
- Manage activities related to complaint follow-up.
- 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.
- Lead Preventive and Corrective Action activities
- Create a positive and collaborative work environment to ensure regulation expectations are achieved.
- Assist in the development and implementation of PXM objectives and strategic initiatives.
- Interpret regulations for execution and recommend modifications to operational procedures to ensure continued compliance.
- Represent Complaint Handling process to external regulators and internal auditors.
- Provide training, coaching and mentoring to team members to optimize performance
- Serve as the manager of a team and actively contribute to talent acquisition and talent management for the department
- Maintain current knowledge on regulatory worldwide requirement for adverse event reporting.
- Identify and participate in continued process improvement of the Complaint Handling and MDR reporting process, including periodic audit and assessment of the function.
- Collaborate with the global complaint handling group to provide appropriate input for the Complaint Handling process.
- Interact with international partners to secure timely reporting of complaint events.
- Ensure team is resourced with appropriate level of talent and expertise to ensure successful execution.
- Ensure the quality/system is planned, understood, implemented and maintained by ensuring compliance within the PXM Department.
- Ensure departmental compliance as well as appropriate departmental resources are available to effectively maintain the complaint handling aspects of the quality system (people, facilities, tools, training)
- Ensure high level of quality and consistency in event decision evaluation and follow-up.
- Function as an advisor to assess and make recommendations to ensure continued FDA and Vigilance Compliance for complaints for the PXM organization.
Must Have: Minimum Requirements
Bachelor’s degree in health care, engineering or bioscience field with 5+ years of medical device experience
Nice to Have
- Experience in complaint management for medical devices and/or pharmaceuticals
- Knowledge and interpretation of MDR/complaint handling regulations
- Demonstrated track record of developing talent and managing people to reach their full potential
- Experience with FDA inspections and responses
- Demonstrated leadership and change management ability
- Process improvement mind-set
- Excellent communication (written and verbal) skills
- Experience in presenting to senior leadership
- Demonstrated strong analytical skills and appropriate use of clinical judgment
- Understanding and application of FDA adverse event reporting requirements
- Proficiency in Microsoft Windows, Excel, Power Point and Excel.
- Demonstrated team building and engagement results
- Demonstrated ability to multi-task and prioritize in a fast paced evolving environment
- Experience interpreting FDA regulations for 803 and 806, QSR, and ISO Standards.
- Experience interfacing directly with FDA contacts.
- Masters in Science or Business Administration or Regulatory Affairs
- Knowledge of Structural Heart products.
- Lean Sigma, CAP and Project Management Skills
- Demonstrated ability to develop and implement metrics and quality expectations
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)