Senior Principle PM Data Analyst
Department: Quality
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Director PMS and QA
Description
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.
Key Responsibilities
- 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.
Skills Knowledge and Expertise
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.