Assoc MDR/Vigilance Specialist

1 month ago


Saint Paul, United States Three Point Solutions Full time
Job DescriptionJob Description

Job Title: Assoc MDR/Vigilance Spec

Client: Medical Device Manufacturing Company

Duration: 2 years

Location: Mounds View, Minnesota 55112

Shift: 1st Shift- Hybrid - Mon/Tues on site/in-office, Wed-Fri remote

Job Description:

HM's Top Needs:

  1. Attention to detail
  2. Critical thinking skills
  3. Excellent written communication skills

Education Required:

  • Bachelor's Degree

Years' Experience Required:

  • 0-2 years

Role Summary:
As an Associate MDR/Vigilance Specialist, you will document and evaluate product feedback and product analysis results to determine complaint status and regulatory reporting status in compliance with US and OUS regulatory guidelines. Compile and submit regulatory agency reports and perform activities to monitor complaint activity, ensuring timely review and follow-up actions related to complaint closure.

Division:
Neuroscience: Develops therapies and healthcare solutions for neurological care, integrating technologies and applying clinical and economic evidence to improve patient outcomes.

A Day in the Life:

Responsibilities include, but are not limited to:

  • Apply policies and procedures to comply with FDA and OUS regulations
  • Monitor the company's drug or medical device surveillance program
  • Evaluate incoming information for Medical Device Reporting and Vigilance reporting eligibility
  • Ensure complete, accurate, and timely submission of Medical Device Reports (MDRs) and Vigilance Reports (VR)
  • Interface and collaborate with internal and external contacts to collect complaint information efficiently
  • Maintain awareness of new products, government regulations, and requirements
  • Act as a liaison to develop programs and processes for regulatory reporting
  • Perform other duties as assigned

Must Have: Minimum Requirements:

  • Bachelor's degree
  • High level of computer proficiency (e.g., Microsoft Office, SAP, Siebel, Oracle Clinical)
  • 0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation

Nice to Have:

  • 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

Specialist Career Stream:

  • Typically an individual contributor with responsibility in a professional discipline or specialty
  • Deliver and manage assigned projects, working with stakeholders to achieve results
  • May mentor colleagues or direct lower-level professionals
  • Majority of time spent delivering and overseeing projects from design to implementation

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 non-complex problems
  • 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 focused on self-development

Required Knowledge and Experience:

  • Broad theoretical job knowledge typically obtained through advanced education
  • Requires a Bachelor's degree (or equivalent for degrees earned outside of the United States)
  • 0 years of experience required
#ZR

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