Post Market Complaint Data Analyst

Role overview

Key responsibilities

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

Education and experience

• A bachelor’s degree in a related field, such as Biomedical Engineering, Life Sciences, or Data Science; experience can offset education.
• At least 2 years of data analysis experience in medical devices, pharmaceuticals, or biotech.
• At least 2 years of post-market complaint handling, investigation, and/or analysis experience.

Skills and knowledge

• Strong analytical skills and ability to interpret complex data sets.
• Proficiency with data analysis tools 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.