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Regulatory Affairs Specialist III-1
Ref No.: 18-10737
Location: Kansas City, Missouri
Title: Regulatory Affairs Specialist III
Location: Kansas City, MO
Duration: 4-8 weeks with possible extensions

Works with the Quality and Compliance department to audit/assess the adequacy of a multi-year Design History File for a medical device product (including device and software). Assess for risk and propose possible remediation to address any risks. Project timeframe: 4-8 weeks.

Tasks and Responsibilities:
  • Audit/assess multi-year Design History File (including product and software)
  • Determine any possible risks
  • Prepare audit/assessment for review
  • Develop possible remediation strategy

Preferred experiential background:
  • 5+ years of experience in Regulatory Affairs
  • 3+ years of experience in an IVD or medical device manufacturing environment
  • Strong knowledge of 21 CFR Part 820.30 Design Controls
  • Strong knowledge/experience conducting quality audits
  • Demonstrated written and verbal communication skills
  • Possesses a high degree of accuracy and attention to detail
  • Ability to work independently, as well as within the team
  • Proficient with Microsoft Office, including: Word, Excel and PowerPoint