Post Market Complaint Data Analyst

Advita Ortho • Gainesville, FL

1d

About The Position

The Medical Device Post-Market Complaint Data Analyst analyzes and manages post-market complaint data to help ensure the safety and efficacy of medical devices. The role works closely with cross-functional teams to provide complete and accurate complaint data that meets business needs and requirements.

Requirements

• At least 2 years of experience in data analysis within the medical device, pharmaceutical, or biotech industries.
• At least 2 years of experience in post-market complaint handling, investigation, and/or analysis.
• Strong analytical skills and the ability to interpret complex data sets.
• Proficiency in data analysis tools and software such as Excel, SAS, R, or Python.
• Excellent communication and presentation skills.
• Detail-oriented with strong organizational skills.
• Knowledge of regulatory requirements such as FDA 21 CFR and ISO 13485.

Responsibilities

• Collect, analyze, and manage post-market complaint data related to medical products.
• Collaborate with Quality Assurance, Regulatory Affairs, Product Development, and other cross-functional teams to meet post-market complaint data needs and requirements.
• Prepare detailed reports and presentations on complaint data analysis for internal and external stakeholders.
• Ensure compliance with regulatory requirements and industry standards.
• Participate in complaint trending activities.
• Participate in root cause analysis and corrective actions.
• Maintain accurate and up-to-date data concerning complaint investigations and resolutions.

What This Job Offers

• Job Type: Full-time