Senior Principal PM Data Analyst
advitaortho · Gainesville
Job description
About the role
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 that protect patients and support regulatory compliance.
Key responsibilities
- Lead enterprise‑wide strategy, analytics, governance, and reporting for post‑market complaint data across products and markets.
- Design and implement advanced trending, signal‑detection, and risk‑monitoring methodologies.
- Establish standardized data definitions, analytical controls, dashboards, and reporting practices.
- Synthesize complaint, investigation, product, and quality‑system data into executive‑level insights for senior leadership.
- Collaborate with Quality Assurance, Regulatory Affairs, Medical/Clinical, and Product Development on cross‑functional initiatives.
- Provide analytical support for regulatory submissions, health‑authority inquiries, inspections, and post‑market surveillance.
- Conduct root‑cause, corrective‑action, and product‑performance analyses with defensible data.
- Evaluate and improve data quality, system controls, and end‑to‑end analytics processes, including automation.
- Develop predictive and statistical models to identify early trends and safety signals.
- Define analytical requirements for systems and data integrations, partnering with technical teams.
- Mentor analysts, review high‑impact analyses, and build organizational capability in complaint analytics.
Required profile
- Bachelor's degree in Biomedical Engineering, Life Sciences, Data Science, Statistics, Engineering, or related field; advanced degree preferred.
- Minimum 10 years of progressive experience in data analytics, quality, post‑market surveillance, or complaint handling within medical device, pharmaceutical, or biotechnology industry.
- At least 5 years of experience leading complex post‑market analytics initiatives.
Required skills
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Published 2 weeks ago
Expires 1 month from now
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advitaortho
Gainesville
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