20 часов назад
MDR/Vigilance Specialist (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
MDR/Vigilance Specialist (Medical Devices): Processing post-market medical device events, determining complaint and reporting status, and completing Medical Device Reports for FDA submission with an accent on complaint investigation accuracy, regulatory compliance, and product knowledge. Focus on evaluating reporting eligibility, maintaining complete event documentation, and supporting inspections and responses to global regulatory agencies.
Location: Mounds View, Minnesota, United States
Company
IT staffing and services company providing talent solutions and professional opportunities through staffing, permanent placement, and vendor management programs.
What you will do
- Process medical device events electronically and determine complaint and reporting status.
- Complete Medical Device Reports and submit them electronically to the FDA.
- Conduct accurate, detailed, and timely complaint investigations and obtain information needed for case closure.
- Collaborate with technical, clinical, field, sales, and returned-product analysis personnel to determine reporting eligibility.
- Maintain accurate event-file data entry, document scanning, and records retention.
- Support regulatory inspections, agency inquiries, post-market quality projects, and compliance procedures.
Requirements
- Bachelor’s degree.
- Less than one year of experience in a health, clinical, technical, or scientific field.
- Working knowledge of post-market quality, complaint handling regulations, and related standards.
- Ability to develop and maintain product knowledge of CRHF products.
Culture & Benefits
- Full-time employment.
- Exposure to FDA and global regulatory agency inspection support.
- Opportunities to contribute to post-market quality and complaint-handling projects.
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