Product Comment Report (PCR) Coordinator

We are seeking a candidate that will be responsible to evaluate and document field reports, product returns, and product analysis results for CRDM products to determine complaint status and US Medical Device Reporting (MDR) eligibility. Investigate specific events by contacting internal resources, company's field employees, company's customers and international staff as appropriate. Collaborate with appropriate technical, clinical and/or returned product analysis employees to determine reporting eligibility. Follow up with clinicians and sales force to gain additional information on reported events. Data entry of complaints.

Job Duties : Conduct follow up of comment/complaint information requests for field and in-house personnel.,Document all information. Ensure the complaint files are complete and maintained properly to satisfactorily meet Q S Reg requirements and to withstand FDA investigations. Assist MDR Specialists in making contacts for investigation of potential MDRs.,Participate in and prepare reports for weekly PCR review meetings.

The ideal candidate must have the following qualifications:

Required:

Education Level:Undergraduate Degree       

Industry Experience:   1 - 3 Years      

Medical device company:Medical device company  

Oral Communication:  Good   Excellent        

 Software Application Knowledge:Acrobat Reader   MS Outlook    MS Word       

Written Communication:Excellent     Good  

Desired:

Industry Experience:   Less than 1 Year        

Software Application Knowledge:     SAP     Document       Business Objects         MS Access      MS Excel            Right Fax       

**Desired experience in Legal, Regulatory, Complaint Handling, or Clinical with a strong knowledge of systems.