14 дней назад
Senior Product Recall Specialist (FDA)
23 - 34$
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
Senior Product Recall Specialist (FDA): Leading and coordinating complex product recall notifications, FDA communications, effectiveness checks, and returned-product processing with an accent on regulatory compliance, audit-ready documentation, and cross-functional execution. Focus on managing FDA inquiries, conducting recall audits, training recall personnel, and improving inspection readiness across regulated quality processes.
Location: Mundelein, Illinois, United States; onsite
Salary: $23.25–$33.75 hourly
Company
is a growing healthcare organization providing medical products and regulated quality operations.
What you will do
- Lead and coordinate sub-recall notifications and company-initiated product recalls under FDA regulations and internal procedures.
- Manage FDA effectiveness checks, regulatory inquiries, follow-up requests, and communications with the FDA district office.
- Oversee returned product areas, return labels, RGAs, credits, replacement products, and vendor reconciliation.
- Maintain complete, accurate, audit-ready recall records and prepare status reports, metrics, and summaries.
- Direct Quality Control activities to identify, segregate, and secure recalled products.
- Train and mentor Recall Specialists while collaborating with Quality, Operations, Sales, vendors, and other stakeholders.
Requirements
- 3–5 years of progressive experience in regulated administrative, quality, or operational roles with direct product recall involvement.
- Experience interacting with regulatory agencies and supporting or leading recall activities is required.
- Strong knowledge of FDA recall requirements, regulated quality processes, and regulatory documentation.
- Clear written and verbal communication, strong organization, attention to detail, and sound judgment with limited supervision.
- Ability to train and mentor recall personnel and manage multiple time-sensitive priorities in a fast-paced environment.
- Advanced proficiency in Microsoft Outlook, Word, and Excel; a high school diploma or GED is required.
Nice to have
- Associate or bachelor’s degree in a related discipline.
Culture & Benefits
- Continuing education and training opportunities.
- Health insurance, life and disability insurance, 401(k) contributions, and paid time off for eligible employees.
- Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for eligible employees.
- Inclusive workplace focused on belonging, diversity, and career growth.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →