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).