Associate MDR/Vigilance Specialist (24 month contract // Mounds View, MN):
Manager Note: Candidates required to work Mon/Tues on site/in-office, but can work Wed-Fri remote
Top 3 things the manager is looking for:
- Medical Device Reporting experience
- Previous healthcare experience
- Medical device industry experience
Top 3 Tasks in Scope for this role:
- Review incoming complaints from the field
- Go back out to the field for further information on complaints
- File regulatory reports
Education Required: Bachelor’s degree
Years’ Experience Required: 0-2 years of quality/regulatory/healthcare experience
Description:
In this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for Medtronic products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission. As part of complaint closure activities this individual performs activities to monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow-up actions that pertain to complaint closure.
Duties:
- Apply policies and procedures to comply with FDA and OUS regulations.
- Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
- Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
- Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
- Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
- Maintain awareness of new products, government regulations and requirements.
- Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
- Other duties as assigned.
Required Skills:
- Bachelor degree
- High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc)
- 0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
Nice to Haves:
- Degree in Health Care, Sciences, or Bio-Medical Engineering
- Medical device industry experience
- Strong verbal and written communication skills
- Knowledge of basic anatomy and physiology
- Strong attention to detail
- High level of computer proficiency
Job Types: Full-time, Contract
Pay: $20.00 - $30.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Schedule:
- Monday to Friday
Education:
- Bachelor's (Preferred)
Experience:
- medical device reporting: 1 year (Preferred)
- hospital/healthcare industry: 1 year (Preferred)
- medical device industry: 1 year (Preferred)
Ability to Commute:
- Mounds View, MN (Required)
Work Location: Hybrid remote in Mounds View, MN
