Regulatory Affairs Specialist

job
  • LanceSoft, Inc.
Job Summary
Location
,MN 55130
Job Type
Contract
Visa
Any Valid Visa
Salary
PayRate
Qualification
BCA
Experience
2Years - 10Years
Posted
05 Jan 2025
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Job Description

Title: Product Surveillance Analyst

Location: St. Paul, MN 55117

Duration: 11 Months


Comments:

  • This position will be located either at our Plymouth, MN, location at 5050 Nathan Lane N, or our St. Paul, MN location @ One St. Jude Medical Drive.
  • The ability to travel to both locations is a requirement. This position will analyze and submit complaints and/or investigate returned products from the field (some biohazard as they are used in surgery).
  • 4-year degree science background; bio, chem, life sciences, etc.
  • Complaint handling, investigation of product performance experience nice to have
  • Highly organized – able to prioritize well
  • Cross functional communication
  • Someone with lab experience for investigation
  • Manage complaint file start to end – good communication
  • Position is contract to hire
  • 100% onsite position – candidates must be local to MN
  • Needs to be someone who can work at Plymouth and/or St. Paul – location may change depending on product and where need is
  • Resumes will be reviewed at the end of this week; interviews to be set up early next


Description:

Experience: 0 - 2 years


Skills :

  • Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred.


Education:

  • Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis.
  • Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.


Duties:

  • May perform multiple functions within the Postmarket surveillance department.
  • Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality.
  • Complete FDA MDR and other outside competent authority regulatory reports.

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