Senior Principle PM Data Analyst

Advita Ortho; Gainesville (FL); On-site; USD 120,000 - 160,000; Full time

Job summary

Advita Ortho in Gainesville, FL is seeking a Senior Principal Post-Market Complaint Data Analyst to lead analytics for post-market surveillance and regulatory reporting. This role drives data governance, advanced trending, signal detection, and provides executive-level insights to cross-functional teams, protecting patients and ensuring regulatory compliance.

The ideal candidate has 10+ years in data analytics within medical devices or biotech and expert skills in SQL, Python, R, SAS, and Power

Qualifications

• Bachelor's degree in Biomedical Engineering, Life Sciences, Data Science, Statistics, Engineering, or related field; advanced degree preferred.
• Minimum of 10 years of progressive data analytics experience in quality, post-market surveillance, or related field in medical devices, pharma, or biotech.
• Minimum of 5 years leading post-market complaint trending, regulatory data reporting, or related analytics.
• Experience influencing enterprise decisions and leading cross-functional initiatives without direct authority.

Responsibilities

• Serve as enterprise SME for post-market complaint analytics, governance, and reporting.
• Design advanced complaint trending, signal-detection, and risk-monitoring methods.
• Establish data definitions, controls, dashboards, and reporting practices.
• Synthesize data into executive-level insights for leadership and governance forums.
• Lead cross-functional analytics initiatives with QA, Regulatory, Medical/Clinical, and Product teams.
• Provide analytical support for regulatory submissions, health authority inquiries, and inspections.
• Direct root cause and CAPA analyses; ensure defensible data-backed conclusions.
• Improve data quality, system controls, and end-to-end complaint analytics processes; pursue automation.

Skills

Statistical analysis

Data visualization

SQL

Python

R

SAS

Power BI

Excel

Education

Bachelor's degree in a relevant field

Advanced degree preferred

Tools

Excel

Power BI

SQL

SAS

R

Python

Job description

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.