CooperSurgical is looking to solve the problem of post market surveillance complaint entry and support of MDR/MDV reporting for their medical devices and Invitro Fertilization products.
Requirements
- Strong operating knowledge of MS Office suite (Outlook, Word, & Excel)
- Well versed with compliance requirements for CFR, ISO, MDSAP, EU MDR, and other regulations
Responsibilities
- 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.
- Performs additional duties or assignments as required by management.
Other
- Excellent verbal, written, presentation skills with attention to detail and the ability to communicate business issues clearly.
- Ability to work independently and in a team setting.
- Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.
- Bachelor's Degree in healthcare related or technical field
- One to three years of previous experience required.
