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).