Associate MDR/Vigilance Specialist
To be considered for this role, please ensure the minimum requirements are evident on your resume.
• 0+ year of related work experience, in areas such as Medical Device Reporting, medical device, medical, clinical, regulatory affairs, quality assurance, or reliability.
• Experience/knowledge of in worldwide adverse event reporting requirements (21 CFR 803, QSR 820, MEDDEV 2.12-1, or Article 253 of Pharmaceutical Affairs Law, etc.)
Nice to Have
•Degree in Medical, Scientific, or Biomedical Engineering field strongly preferred.
• Experience/knowledge of in worldwide adverse event reporting requirements (21 CFR 803, QSR 820, MEDDEV 2.12-1, or Article 253 of Pharmaceutical Affairs Law, etc.)
• Solid understanding and application of business concepts and practices.
• Clinical and/or regulatory background.
• Knowledge of Diabetes products and therapies.
• Effective priority setting and multi-tasking management.
• Excellent knowledge of word processing, spreadsheet, database and graphics presentation applications.
• Strong oral and written communication skills
• Record management experience.
• Strong judgment and problem resolution skills.
• Effective at developing and maintaining strong interpersonal and team relationships to facilitate completion of assignments.
• Previous experience that includes complaint communications and/or completion of regulatory reports
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)
