The Product Surveillance Associate II reviews, evaluates, and investigates product complaints relative to the identity, quality, reliability, safety, and effectiveness of CooperSurgical Medical Device and Invitro Fertilization products. The Product Surveillance Associate II is experienced in complaint handling activities and categorizing complaints to comply with current FDA and international reporting regulations. Duties also include supporting the intake of complaints from various sources, initial screening of essential complaint details, Good Faith Effort Follow ups for additional information, Medical Device Reporting (MDR)/Medical Device Vigilance (MDV) determination, investigation assignment, as well as various complaint process activities. In addition to, supporting recall and related field actions in the form of preparing technical documentation and coordinating associated activities.
The Product Surveillance Associate II must have excellent customer service skills, the ability to evaluate, disseminate, and present information from a global perspective.
- Evaluates incoming complaint information and maintains it in the electronic database.
- Works closely with customers and sales representatives to obtain additional complaint information and respond to complaint reports.
- Determines reportability (MDR/Adverse Event) of complaints to FDA and other international regulatory agencies.
- Closely monitors quality, completeness, and timeliness of complaint intake information, reportability assessments, and investigation assignments.
- Triages and escalates product/ patient safety or compliance issues to management for immediate attention.
- Participates in team decision making, weekly reportability assessments, and displays team problem solving/communication skills.
- Prepare Health Hazard Evaluations, 806 & Field Safety Corrective Action Reports, and customer notifications.
- Well versed with compliance requirements for CFR, ISO, MDSAP, EU MDR, and other regulations.
- Provides guidance and training to support staff and new associates.
- Performs additional duties or assignments as required by management.
- Bachelor's Degree preferred or equivalent experience in healthcare related or technical field. One year of previous experience required.
- Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.
- Ability to work independently and in a team setting.
- Excellent verbal, written, presentation skills with attention to detail and the ability to communicate business issues clearly.
- Strong operating knowledge of MS Office suite (Outlook, Word, & Excel).