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  • Fort Lauderdale, FL

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Compliance Analyst

Hunter Hollis • Fort Lauderdale, FL

Posted 1 month ago

Job Snapshot

Travel - None
Experience - 5 to 99 years
Degree - 4 Year Degree
• Medical, Dental, Vision, Disability, and Life Insurance
Medical Equipment
QA - Quality Control

Job Description

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

Job Requirements

          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

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