Analyst, Product Surveillance III

Primary Responsibilities

• Evaluate, investigate, document, and close complex medical device complaint records.
• Support global vigilance reporting and reportability assessments.
• Perform detailed quality reviews of complaint files to ensure compliance and data integrity.
• Analyze complaint data, identify trends, and support CAPA investigations, risk assessments, and continuous improvement initiatives.
• Develop and maintain complaint metrics, dashboards, and reporting to support business and quality objectives.
• Author, revise, and redline complaint handling procedures, work instructions, forms, and training materials.
• Provide guidance and mentorship to complaint evaluation and closure teams.
• Support regulatory inspections, internal audits, and health authority inquiries.
• Collaborate with Regulatory Affairs, Medical Events, Engineering, Quality Compliance, Track & Trend teams, and Customer Service functions.
• Support strategic post-market surveillance initiatives and special projects.

Required Experience & Skills

• 5-8 years of medical device complaint handling or post-market surveillance experience.
• Strong working knowledge of 21 CFR Part 820, Complaint Files (198), 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR, and medical device quality systems.
• Demonstrated experience independently evaluating, investigating, and closing complex medical device complaints.
• Experience supporting adverse event reporting, complaint investigations, CAPA activities, complaint trending, and regulatory assessments.
• Strong data analysis skills with the ability to identify trends, assess risk, and support data-driven decisions.
• Advanced proficiency with Microsoft Excel and Microsoft Office Suite (Word, PowerPoint, Outlook).
• Experience working with SQL, Salesforce, complaint handling systems, and electronic quality management systems (eQMS).
• Strong technical writing, documentation, communication, and problem-solving skills.