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