Analyst II

Analyst II – Post-Market Surveillance
Competitive Pay – Desirable Hours – Potential for Hybrid Work!

  • Initiates and manages the complaint file
  • Maintains accurate entry of complaints in the database
  • Communicates to field representatives regarding information needed specifically to product complaints (e.g., physicians, hospital personnel, sales representatives, international offices)
  • Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, ECA) and submits reports within required timeframe
  • Diligent of any unusual trends in product complaints and communicates them with mgmt.
  • Complies with US FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, and contractors.
  • Performs other related duties and responsibilities as assigned


  • Bachelor of Science in Biology, Chemistry, or related science
  • 0-3 years of experience in the Medical Device industry (preferred)
    • Applicable experience also includes regulatory, clinical/medical, quality assurance, or related
  • Microsoft Office experience required
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