Complaint Analyst, Regulatory and Compliance

- This position is responsible for handling product complaints to ensure compliance with US and International regulatory agencies.
- This person will participates in cross functional teams in evaluation of products to help determine root cause of, and corrective action for, product problems related to reported customer complaints and Adverse Events.
- He/she will be aware of new and emerging global reporting requirements throughout the organization. 

RESPONSIBILITIES: 

- Identify product complaints per regulatory definition. 
- Accurately enter complaint data into the designated complaint handling database. 
- In accordance with internal and external (FDA, Canadian and European) regulatory requirements, complete assigned investigations from initial receipt of complaint to identification of root cause and closure. 
- Document investigations in a clear and concise manner in accordance with documented processes. 
- Interface directly with customers, physicians, field service engineers, clinical personnel, and technical experts to collect basic facts related to a reported issue and follow up if necessary. 
- Complete investigations in a timely manner per defined metrics. 
- Identify potential safety problems and ensure investigations for reportable safety events are compliant with worldwide regulations. 
- Participate in, and contribute to, Health Risk Assessments. 

9. Research company documentation to reference in the complaint record and/or safety committee presentations.  - Perform trend analysis of product quality data to identify adverse trends that may warrant corrective action. 
- As an advocate of the customer, represent Q&R on reliability teams, post release teams, CAPA teams, etc. to help drive reliability improvements to ChMV products.