Tekwissen - Analyst, Safety Regulatory Reporting and Global Complaints - ICU Medical

3 weeks ago


Minneapolis, United States TekWissen LLC Full time
Job DescriptionJob DescriptionOverview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is a, passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. A leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world's healthcare markets. Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services. Job Id: 2824Position: Analyst, Safety Regulatory Reporting and Global Compliants - Contract Location: 6000 Nathan Lane N, Plymouth, MN 55442 United States Duration: 6+ Months, Possible Extension Job Type: Contract Work Type: Onsite, Later Remote after 2 weeks training Shift: ((Mon-Fri)(8.00AM-4.30PM) Pay Rate: $35.00/hour 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.
  • Client FDA Medical Device Reporting and experience with Trackwise Digital preferred.
Work Environment
  • This is largely a sedentary role.
  • This job operates in a professional office environment and routinely uses standard office equipment.
Responsibilities: 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.
TekWissen Group is an equal opportunity employer supporting workforce diversity.

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