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Assoc MDR/Vigilance Spec - Exempt
Assoc MDR/Vigilance Spec - ExemptThree Point Solutions Inc • Mounds View, MN, US
Assoc MDR / Vigilance Spec - Exempt

Assoc MDR / Vigilance Spec - Exempt

Three Point Solutions Inc • Mounds View, MN, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Job Title : Assoc MDR / Vigilance Specialist

Client : Medical Device Manufacturing Company

Duration : 2 Years (possible extension)

Location : Mounds View, MN 55112 (Onsite, 4 days / week)

Shift : 1st Shift

Overview :

Responsible for documenting and evaluating product feedback and analysis results to determine complaint and regulatory reporting status per FDA and OUS guidelines. Supports surveillance of medical devices and ensures timely submission of Medical Device Reports (MDRs) and Vigilance Reports (VRs).

Top Skills :

  • Nursing / medical background or clinical experience with medical devices
  • Biomedical Engineering or Biomedical Neuroscience education
  • Pre-med or biological sciences background (Anatomy, Physiology, etc.)

Education & Experience :

  • Bachelor’s degree (Science or related field)
  • 0–2 years of experience in healthcare, pharma, or medical device industry
  • Strong computer proficiency (MS Office, SAP, Siebel, Oracle Clinical)

    • Key Responsibilities :

  • Evaluate and document complaints to determine MDR / Vigilance eligibility
  • Compile and submit regulatory reports to FDA and international agencies
  • Monitor complaint activities and ensure timely closure and compliance
  • Collaborate with internal teams and external partners to gather information
  • Maintain awareness of regulations and product updates
  • Support safety data review, ADE data extraction, and reporting accuracy

    • Preferred Qualifications :

  • Degree in Nursing, Biology, Pre-Med, or Biomedical Engineering
  • Knowledge of anatomy and physiology
  • Strong written and verbal communication
  • Detail-oriented with high accuracy in documentation

    • #ZR

    Company Description

    As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.

    Company Description

    As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.

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    Spec • Mounds View, MN, US