apartmentPlatinum Supplemental InsuranceplaceEagan
If you’re exploring sales careers, you already know sales is the way to get ahead. Have you ever noticed that the most successful sales people receive superior support from the companies they work with? A robust company like Platinum handles objectives like marketing, recruiting, customer service, a...
apartmentPlatinum Supplemental InsuranceplaceBloomington
If you’re exploring sales careers, you already know sales is the way to get ahead. Have you ever noticed that the most successful sales people receive superior support from the companies they work with? A robust company like Platinum handles objectives like marketing, recruiting, customer service, a...
apartmentPlatinum Supplemental InsuranceplaceBurnsville
If you’re exploring sales careers, you already know sales is the way to get ahead. Have you ever noticed that the most successful sales people receive superior support from the companies they work with? A robust company like Platinum handles objectives like marketing, recruiting, customer service, a...
apartmentAxelon Services CorporationplaceSaint Paul, 19 mi from Plymouth (MN)
Job Title : Medical Device Assembler I Location: Saint Paul, MN Shift: 5 AM - 3:30 PM (Mon - Thurs) Job Description: "This is a non-exempt position. This position is responsible for the production of high quality medical devices within...
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Analyst, Product Surveillance

apartmentAxelon Services CorporationplacePlymouth (MN)
Title: Product Surveillance Analyst (ONSITE) Location: Plymouth,MN Timings: 8AM - 4PM (Monday to Friday) Exempt/Non Exempt Non ExemptYears Experience: 0 - 2 yearsSkills: Related experience in post market surveillance in a Medical Device...
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Analyst, Product Surveillance

apartmentICONMA, LLCplacePlymouth (MN)
Analyst, Product Surveillance Location: Plymouth, MN Duration: 12 months Description: Years Experience: 0 - 2 years Skills: Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred. Education...
apartmentHEPCOplaceMinneapolis
As a Senior Mechanical Engineer, you will be responsible for researching, planning, analyzing, designing, and developing mechanical products such as ammunition handling systems, structures, gun systems, missile launchers, mechanisms, and other devices. We are seeking a highly skilled Senior Mechanic...
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Manufacturing Engineer

apartmentSelect Source International Pvt LtdplaceMinnetonka, 4 mi from Plymouth (MN)
Client: Medical Device Role: Manufacturing EngineerDuration: 6 MonthsLocation: Minnetonka, MN 55345 The Opportunity This position works out of our Minnetonka, MN location, supporting our Medical Device division.As a Process D...
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Analyst, Safety Regulatory Reporting and Global Compliants

LanceSoft Inc | Plymouth | www.resume-library.com |
Title : Analyst, Safety Regulatory Reporting and Global Complaints
Location : 6000 Nathan Lane N, Plymouth, MN 55442 United States
Duration : 6 Months contract

Job description:

Qualifications:

Must be at least 18 years of age.

High School Diploma required.

Bachelors Degree in Engineering, Medical Sciences, or other related scientific field required.

2+ years experience in a health care environment, and/or within a quality/compliance/regulatory organization in an FDA regulated business preferred.

US FDA Medical Device Reporting and experience with Trackwise Digital preferred.

Position Summary

The temporary position is responsible for managing device complaints and adverse events globally. This may include: complaint initial triage, submitting regulatory reports in accordance with applicable regulations, referring potential safety cases to applicable department, providing updates to reports, reviewing for closure/reopening as needed, and assuring timely processing of complaints.

Essential Duties & Responsibilities

Responsible for evaluating complaints from patient safety perspective and completing regulatory reporting decisions per reporting requirements globally.

Responsible for creating and submitting regulatory reports to the FDA.

Works independently and is accountable for completing task as assigned.

Works well in a team to accomplish team goals.

Knowledge & Skills

Experience with or knowledge of medical terminology and how medical/pharmaceutical products are typically used in a clinical setting.

Basic computer and software skills.

Must be able to communicate effectively with internal and external customers.

Demonstrate ability to collect, analyze and interpret complaint and adverse event information.