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Post Market Surveillance Specialist

Company: Redbock - an NES Global Talent company
Location: Boulder
Posted on: August 3, 2022

Job Description:

Post-Market Vigilance Specialist (Through Mid-January 2023 // Boulder, CO):TOP SKILLS REQUIRED:

  • Computer skills - Microsoft Office - Outlook, Word and Excel. Including ability to type the English language proficiently.
  • Adaptable - able to fluctuate between multiple activities/task.
  • Any previous experience with Quality Assurance or Complaint Handling is preferred but not requiredLocal candidates needed to sit on site: 2 days in office 3 days remote.Duties:
  • Supports intake evaluation, processing, and communications and investigations on complaints and adverse events according to procedures and government regulations.
  • Provides administrative expertise in receipt, processing and reporting of product defect complaints, serving as primary contact.
  • Ensures complete and accurate records and reporting of Medical Device Reports or adverse events as required by regulatory agencies.
  • Addresses and expedites product complaints under the company's complaint policy and procedures and ensures compliance with government regulations.
  • Monitors complaint activity and provides suggestions to appropriate company authorities to modify existing manufacturing or packaging process based upon pattern and related analyses.
  • Provides technical expertise to optimize complaint processing systems.
  • Maintains and monitors systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure Supports projects to develop or enhance programs and processes to meet regulatory reporting requirements.REQUIRED KNOWLEDGE AND EXPERIENCE:Minimum of Bachelor's degree with a preference to science, health care or engineering degree and 0-2 years of relevant experience.PREFERRED QUALIFICATIONS:
    • To be successful in this role, the candidate will need to be a self-starter, self-motivating, detail-oriented, able to work at a computer/desk setting, proficient in the English language, able to type proficiently, and skilled at technical writing. Additionally, some knowledge of medical terminology and experience working in databases will be beneficial to this candidate's success. Some knowledge of good documentation practices (GDP), good manufacturing practices (GMP) and quality systems in a regulated environment would also be beneficial.

Keywords: Redbock - an NES Global Talent company, Boulder , Post Market Surveillance Specialist, Other , Boulder, Colorado

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