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MDR specialist
Contract: Mounds View, Minnesota, US
Salary Range: 25.00 - 26.00 | Per Hour
Job Code: 362797
End Date: 2025-07-10
Days Left: 21 days, 14 hours left
Position Details:
Industry Medical Device
Job Title Associate MDR/Vigilance Specialist
Work Location Mounds View MN - 55112
Duration 24+ months
Pay Range $25-26
Job Description:
Education Required: Bachelors Degree
Years’ Experience Required: 0-2 years
Will the contractor be working 40 hours a week? If not, weekly estimate? 40/week
Work Location: Mounds View Campus
Do they need to be local to any MDT office and if so where?
Does this person need to be on site? If so, full time or part time? Mon/Tues on site/in-office, Wed-Fri remote
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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 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.
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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.
Neuroscience
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The Neuroscience Portfolio group develops life-restoring therapies and healthcare solutions that span the neurological care continuum including 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
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Responsibilities include the following but not limited to:
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Apply policies and procedures to comply with FDA and OUS regulations.
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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.
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Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
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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.
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Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
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Maintain awareness of new products, government regulations and requirements.
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Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
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Other duties as assigned.
Must Have: Minimum Requirements
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To be considered for this role, please ensure the minimum requirements are evident on your resume.
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Bachelor degree
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High level of computer proficiency (e.g. MS Office, SAP, Siebel, Oracle Clinical, etc)
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0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
Nice to Have
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Degree in Health Care, Sciences, or Bio-Medical Engineering
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Medical device industry experience
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Strong verbal and written communication skills
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Knowledge of basic anatomy and physiology
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Strong attention to detail
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High level of computer proficiency
Job responsibilities:
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Responsibilities may include the following and other duties may be assigned.
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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.
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Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
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Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
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Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
SPECIALIST CAREER STREAM:
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Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
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May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
- Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.
- Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
- Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
- Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.
- Leadership and Talent Management: N / A – job at this level is focused on self-development.
- Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
- Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.
Job Requirement
- bachelors
- neuroscience
- MS office
- Medical device
- Pharmaceutical
Reach Out to a Recruiter
- Recruiter
- Phone
- Srividhya M
- srividhya.m@collabera.com
Apply Now
Apply Now
