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Company Contact Info
- Fort Lauderdale, FL
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Hunter Hollis • Fort Lauderdale, FL
Posted 1 month ago
The Global Regulatory Compliance Analyst reviews product complaint records for reportability, prepares, reviews and submits initial and supplemental adverse event/incident Reports to FDA (as well as global regulatory authorities), for a variety of products (medical device, foods, dietary supplements, OTC drug) as required. Interacts/communicates with internal customers to assure regulatory compliance is maintained.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Understand complaint handling process from initiation to closure.
• Utilize complaint handling software application to perform essential duties
• Independently review/analyze complaint-related databases, records and documents to determine reportability, including supplemental Reports
• Organize and prioritize documentation used to manage daily activities and submit Reports
• Review and revise complaint reporting procedures as needed.
• Provide Company subsidiaries with support related to complaint Reporting compliance
• Assist with administrative regulatory activities as needed to support Projects and product registrations.
• Support Post-Market Review trending activities:
- Review and analyze own-brand product complaints
- Compile, review and analyze the FDA MAUDE database monthly
- Other, as assigned
• Participate in GMP audits, as needed
• Experience in medical device complaint handling /MDR reporting
• Demonstrated independence and self-motivation
• 5+ years in a GMP/ISO regulated environment
• Proficient skills with MS Office Suite (Excel, Word, PowerPoint, Outlook) and SharePoint
• Interdepartmental Communication skills