Senior Principle PM Data Analyst

Company: advitaortho
Location: Gainesville, Florida
Type: onsite
Posted: Aug 31, 2026
Views: 0

✨ AI Summary

AdvitaOrtho, a medical device company, is hiring a Senior Principal Post-Market Complaint Data Analyst in Gainesville, Florida. The role focuses on complaint analytics, signal detection, and regulatory reporting using tools like SQL, Power BI, SAS, R, and Python. Candidates require a minimum of 10 years of experience in data analytics or quality within the medical device industry, with at least 5 years leading post-market surveillance initiatives.

The Senior Principal Post-Market Complaint Data Analyst serves as the enterprise subject matter expert for post-market complaint analytics, providing strategic leadership for data governance, advanced trending, signal detection, and regulatory reporting. This role translates complex global complaint and product-performance data into actionable insights, establishes analytical standards, and influences cross-functional decisions that protect patients, strengthen product quality, and support sustained regulatory compliance.
  • Serve as the enterprise subject matter expert for post-market complaint data strategy, analytics, governance, and reporting across products and markets.
  • Design and lead advanced complaint trending, signal-detection, and risk-monitoring methodologies to identify emerging product, patient, and quality concerns.
  • Establish standardized data definitions, analytical controls, dashboards, and reporting practices that improve accuracy, traceability, and audit readiness.
  • Synthesize complex complaint, investigation, product, and quality-system data into executive-level insights and recommendations for senior leadership and governance forums.
  • Lead cross-functional analytical initiatives with Quality Assurance, Regulatory Affairs, Medical/Clinical, and Product Development.
  • Provide expert analytical support for regulatory submissions, health authority inquiries, inspections, management reviews, risk management, and post-market surveillance activities.
  • Direct complex root cause, corrective and preventive action, and product-performance analyses; challenge assumptions and ensure conclusions are supported by defensible data.
  • Evaluate and improve data quality, system controls, and end-to-end complaint analytics processes; develop scalable automation and continuous-improvement solutions.
  • Develop predictive and statistical models, where appropriate, to improve early identification of trends, outliers, and potential safety signals.
  • Define analytical requirements for systems and data integrations and partner with technical teams to validate outputs and maintain data integrity.
  • Mentor analysts and cross-functional partners, provide technical review of high-impact analyses, and build organizational capability in complaint analytics.
  • Represent the complaint analytics function on strategic programs and communicate complex findings clearly to technical, regulatory, and executive audiences.
Education:
  • Bachelor's degree in Biomedical Engineering, Life Sciences, Data Science, Statistics, Engineering, or a related field. Advanced degree preferred. Significant directly relevant experience may offset education.
Experience:
  • Minimum of 10 years of progressive experience in data analytics, quality, post-market surveillance, complaint handling, or a related discipline within the medical device, pharmaceutical, or biotechnology industry.
  • Minimum of 5 years of experience leading complex post-market complaint trending, investigation analytics, signal detection, or regulatory data reporting.
  • Demonstrated experience influencing enterprise-level decisions and leading cross-functional initiatives without relying on direct authority.
  • Experience supporting regulatory inspections, health authority responses, management review, risk management, and/or corrective and preventive action activities.
Functional/Technical Knowledge, Skills and Abilities Required:
  • Expert knowledge of global medical device post-market surveillance and quality-system expectations, including applicable FDA requirements and ISO 13485. Knowledge of ISO 14971 and international vigilance requirements strongly preferred.
  • Advanced expertise in statistical analysis, data visualization, and interpretation of large, complex, and imperfect data sets.
  • Advanced proficiency with analytical and reporting tools such as Excel, Power BI, SQL, SAS, R, Python, or comparable platforms.
  • Demonstrated ability to design data governance standards, analytical controls, metrics, dashboards, and scalable reporting solutions.
  • Strong business judgment and the ability to translate technical findings into clear risk-based recommendations for executive and regulatory audiences.
  • Exceptional written, verbal, presentation, stakeholder-management, and technical-mentoring skills.
  • Ability to independently lead high-impact work, manage ambiguity, prioritize competing demands, and maintain rigorous attention to data integrity and documentation.
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