Senior Principle PM Data Analyst

Advita Ortho•Gainesville, FL

6d•Onsite

About The Position

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.

Requirements

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.
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.
Expert knowledge of global medical device post-market surveillance and quality-system expectations, including applicable FDA requirements and ISO 13485.
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.

Nice To Haves

Knowledge of ISO 14971 and international vigilance requirements strongly preferred.

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.