Assoc MDR/Vigilance Specialist

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.

Additional Skills & Qualifications

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. 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. 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. 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. Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. SPECIALIST CAREER STREAM: Typically an individual contributor with r

This is a Contract position based out of Mounds View, MN.

The pay range for this position is $27.00 - $27.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Mounds View,MN.

This position is anticipated to close on Apr 30, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $27