Post Market Complaint Data Analyst
Advita Ortho
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- Location
- Gainesville, FL
- Work style
- On-site
- Job type
- Full time
- Posted
- Oct 16
- 3 days ago
Career path
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About the company
Advita Ortho
Medical devices · 2 to 10 employees
What you'll do
- Bachelor's degree in a related field (e.g., Biomedical Engineering, Life Sciences, Data Science). Experience can offset education.
- 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.
- 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).
What you need
- 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.
- Education: a bachelor's degree
Key skills
Strong analytical skillsExcelSASRPythoncommunication skillspresentation skillsorganizational skillsFDA 21 CFRISO 13485
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Read the full posting here
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 ResponsibilitiesCollect, analyze, and manage post-market complaint data related to medical productsCollaborate 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 ExpertiseEducation: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).