Product Surveillance Activities
Field inquiries received by phone, electronic or verbal correspondence and document reported complaints according to applicable SOP(s).
Provide technical support and remote troubleshooting guidance as needed.
Review associated records; provide technical guidance, and contact users and customers to collect information on the treatment, product performance, functionality, etc.
Conduct periodic follow-up to close complaints in a timely manner.
Complete investigations, which may include execution or coordination of product returns and subsequent evaluations, review of manufacturing records and ensuring proper approvals are obtained as part of closure.
Support statistical analysis of complaint trends.
Process Improvement Initiatives
Recommend operational changes to improve efficiencies in all aspects of complaint handling.
Adherence to Regulations
Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.
Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting.
Associates Degree in nursing, pharmacy, medical technology, engineering or scientific background preferred
Professional experience
Medical Device preferred
Medical or surgical office experience preferred
Customer service experience required
Requires Vision Assessment (20/20 near visual acuity & acceptable color vision)
This position will *** per hour •
Last updated on Apr 17, 2023