Associate MDR / Vigilance Specialist - Remote

Overview

The Associate MDR/Vigilance Specialist at Medtronic is responsible for documenting and evaluating product feedback and product analysis results to determine complaint status and regulatory reporting status in alignment with US and OUS regulatory guidelines.

In Short

• Document and evaluate product feedback for Medtronic products.
• Compile regulatory agency reports for submission.
• Monitor complaint activity for timely review and follow-up.
• Ensure compliance with FDA and OUS regulations.
• Evaluate incoming information for Medical Device Reporting eligibility.
• Interface with internal and external contacts to collect complaint information.
• Maintain awareness of new products and government regulations.
• Act as a liaison to develop programs meeting regulatory requirements.
• Strong attention to detail and communication skills required.
• Must hold a Bachelor’s Degree; experience in the medical device industry is a plus.

Requirements

• Bachelor’s Degree with 0 years of work experience.
• Degree in Health Care, Sciences, or Bio-Medical Engineering preferred.
• Medical device industry experience is a plus.
• Strong verbal and written communication skills.
• Knowledge of basic anatomy and physiology.
• High level of computer proficiency (Microsoft Office, SAP, Siebel, Oracle Clinical).
• Attention to detail.

Benefits

• Competitive salary and flexible benefits package.
• Health, Dental, and vision insurance.
• Health Savings Account and Healthcare Flexible Spending Account.
• Life insurance and long-term disability leave.
• Tuition assistance/reimbursement.
• Incentive plans and 401(k) plan with employer contribution.
• Paid time off and paid holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Commitment to diversity and equal opportunity.