обновлено 14 дней назад
Regulatory Reporting Specialist (Medical Devices)
67 000 - 101 000$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
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TL;DR
Regulatory Reporting Specialist (Medical Devices) (FDA MDR/21 CFR 803): Reviewing product complaints and determining reportability for medical device events, with an accent on complaint remediation, regulatory decision logic, and eMDR submissions. Focus on analyzing medical and product information, completing FDA-compliant reports, and coordinating high-volume retrospective reviews with Quality, Regulatory Affairs, R&D, and Operations.
Location: Mundelein, Illinois, United States; onsite
Salary: $67,000–$101,000 annual; bonus and/or incentive eligible
Company
is a worldwide medical products organization offering regulated medical device and healthcare solutions.
What you will do
- Review new and historical product complaints for data completeness and MDR reportability.
- Evaluate complaint files under FDA 21 CFR 803 and current internal decision criteria.
- Gather missing complaint and product information with Quality, Regulatory Affairs, R&D, Operations, and other partners.
- Prepare and submit reportable events through the FDA eMDR portal.
- Coordinate with international regulatory contacts on global reporting obligations when needed.
Requirements
- Bachelor’s degree in a relevant field and at least 1 year of experience in complaint handling, MDR evaluation, post-market surveillance, regulatory affairs, or a related regulated industry.
- Basic knowledge of FDA Medical Device Reporting, 21 CFR 803, and complaint handling requirements under 21 CFR 820.198.
- Ability to interpret medical descriptions, product information, and complaint narratives to assess event severity and regulatory obligations.
- Strong analytical, critical-thinking, communication, prioritization, and collaboration skills.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
Nice to have
- Two or more years of experience in complaint remediation, MDR reporting, or similar work in a medical device, pharmaceutical, or healthcare environment.
- Experience with large-scale retrospective reviews or high-volume documentation processing.
- Familiarity with SAP, TrackWise, or similar complaint management systems.
Culture & Benefits
- Competitive total rewards package with health insurance, life and disability coverage, 401(k) contributions, and paid time off.
- Continuing education and training opportunities.
- Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for eligible employees.
- Inclusive workplace focused on belonging, career growth, and equal employment opportunity.
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