Consumer Affairs Specialist - 25632
New Contract Opportunity in North Haven, CT
TITLE: Consumer Affairs Specialist - 25632
The PMV Analyst I position is responsible for monitoring, tracking and trending product complaints to assure compliance with Competent Authorities worldwide. Duties include intake and closure of complaint files and in-depth trend analysis. The candidate must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective. This entry level position requires an eye for detail and excellent organizational skills.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Working within a product team with PMV Analysts at various levels:
- Complaint entry, coding and closure using current systems.
- Maintain the highest level of compliance to the Code of Federal Regulations, Medical Device Directive (European Union), Canadian Medical Device Regulations, Japan MHLW, China SFDA and Australian Regulations. Including the preparation and timely submission of all Medical Device Reports and Medical Device Vigilance reports with a focus on accuracy, precision and urgency.
- Tracking and trending of complaints.
- Closely monitor quality and timeliness of complaint files.
- Provide/ present data/ trends to other departments as necessary.
- Ensure obligations to internal/external customers are being performed in an accurate and timely fashion.
- Medical device experience desirable
- Self-starter with proven ability to successfully work with minimal supervision
- Strong operating knowledge of Word, Excel and PowerPoint computer applications
- Knowledge of quality control concepts desirable
- Excellent presentation and customer service skills
- Strong analytical skills including trend and statistical analysis
- Detail oriented and highly organized
- Demonstrated ability to communicate clearly both verbally and in writing
- Bachelor's degree required. Degree in Science related discipline preferred.