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Advita Ortho

Post Market Complaint Data Analyst

Advita Ortho Gainesville, Florida, United States

Medical Equipment Manufacturing · 501-1,000 employees

6 h ago
data-analyst Mid (2-5 yrs) Full-time United States
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About the role

The analyst will collect, manage, and analyze post-market complaint data to ensure medical device safety and regulatory compliance. They will collaborate with cross-functional teams to perform root cause analysis and prepare detailed reports for stakeholders.

What they look for

Data analysis Medical device regulation Complaint handling Root cause analysis Excel SAS R Python Quality assurance Regulatory affairs FDA 21 CFR ISO 13485 Technical reporting Data management Communication Organizational skills

Requirements

Candidates must have at least 2 years of experience in data analysis within the medical device, pharmaceutical, or biotech industries. A bachelor's degree in a related field such as Biomedical Engineering, Life Sciences, or Data Science is required.

Full description

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).

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