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Job Title: Associate MDR/Vigilance Specialist Job Description

We are seeking a detail-oriented Associate MDR/Vigilance Specialist to join our team. This role involves reviewing product events from various sources to determine complaint status and creating thorough complaint records in our complaint handling system. The position requires critical thinking skills, strong attention to detail, and excellent writing ability.

Responsibilities

+ Review product events from various sources to determine complaint status.

+ Create thorough complaint records in the complaint handling system.

+ Determine if all relevant complaint information is provided and conduct follow-up as needed.

+ Determine regulatory reporting status and complete regulatory reports while ensuring timeliness requirements are met.

+ Participate in continuous improvement activities as assigned.

+ Monitor the company's drug or medical devices surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports.

+ Participate in the resolution of any legal liability and ensure compliance with government regulations.

+ Ensure 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 integrate the data to ensure the creation of a unified database.

+ Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

Essential Skills

+ Bachelor's degree is required, preferably in biomedical engineering or as a healthcare professional nurse.

+ Broad theoretical job knowledge typically obtained through advanced education.

+ Strong critical thinking skills.

+ Attention to detail.

+ Excellent writing ability.

Additional Skills & Qualifications

+ Experience in complaint handling and quality assurance.

+ Experience with biomedical engineering or healthcare professional roles.

Work Environment

The position requires working on-site at the Mounds View, MN location four days a week. Candidates must be local to the Minneapolis/St. Paul area. This role involves working 40 hours a week and engaging primarily with internal contacts within the immediate group. The work may involve delivering and managing projects from design to implementation while adhering to company policies.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $25.25 - $25.25/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)

Workplace Type

This is a hybrid position in Minneapolis,MN.

Application Deadline

This position is anticipated to close on Oct 30, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.