Post Market Complaint Data Analyst

Post Market Complaint Data Analyst

Department

Quality

Employment Type

Full Time

Location

Gainesville, FL

Reporting To

Director, Post Market Surveillance and Clinical Affairs

Description

The Medical Device Post-Market Complaint Data Analyst plays a crucial role in ensuring the safety and efficacy of our medical devices by analyzing and managing post-market complaint data. This role will work closely with cross-functional teams, providing complete and accurate post-market complaint data to meet business needs and requirements.

Key Responsibilities

• Collect, analyze, and manage post-market complaint data related to medical products
• Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Product Development, to ensure post-market complaint data needs and requirements are met.
• 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 all complaint investigations and resolutions.

Skills Knowledge and Expertise

Education

• Bachelor's degree in a related field (e.g., Biomedical Engineering, Life Sciences, Data Science). Experience can offset education.

Experience

• Minimum of 2 years of experience in data analysis within the medical device, pharmaceutical, or biotech industries.
• Minimum of 2 years of experience in post-market complaint handling, investigation, and/or analysis.

Functional/Technical Knowledge, Skills and Abilities Required

• Strong analytical skills with the ability to interpret complex data sets.
• Proficiency in data analysis tools and software (e.g., Excel, SAS, R, Python).
• Excellent communication and presentation skills.
• Detail-oriented with strong organizational skills.
• Knowledge of regulatory requirements (e.g., FDA 21 CFR, ISO 13485).