Careers That Change Lives In this exciting role in Medtronic’s the Associate MDR/Vigilance Specialist will be responsible for the intake, documentation, Medical Device Reporting, and investigation of complaints for Pelvic Health products in accordance with applicable internal procedures (work instructions) and external requirements (regulations or guidance from any and all regulatory bodies). The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. A Day in the Life Responsibilities may include the following and other duties may be assigned. - 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. - Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. - Receive and assess product comments to determine need for complaint handling record. - Document required information in Global Complaint Handling database - Assess complaint file for missing required information. If information is missing, initiate attempts to gather information by contacting field personal, health care providers, and patients. - Evaluate incoming product events to determine Medical Device Reporting and Vigilance Reporting eligibility. - Initiate, complete regulatory reports for timely submission to FDA and other regulatory bodies. - Determine potential cause and contributing factors to the alleged event, device relationship, and if additional assessment of the issue is necessary. - Drive process improvement through issue identification, problem solving, and collaboration with functional partners. Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume. - Bachelors degree required - 0 years of experience required Nice to Have - Complaint handling experience or customer service/technical support experience (0-2 years) - Strong critical thinking and analytical skills - Demonstrated performance to challenging goals - Excellent communication (oral and written) with strong organizational ability - Knowledge of basic anatomy, physiology, and medical terminology - Knowledge of: - 21CFR, Section 820, Quality System Regulation - 21CFR Section 803, Medical Device Reporting - ISO 13485, Quality Systems, Quality Management Systems - 45CFR, Parts 160 and 164, Patient Privacy Rule- HIPPA Regulations About Medtronic 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) Additional Information - Posting Date: Dec 17, 2020 - Travel: No
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