Director of Quality Analytics & Regulatory Readiness

Integra LifeSciences Corporation; Columbia (MD); On-site; USD 167,000 - 229,000; Full time

Job summary

Integra LifeSciences seeks a seasoned Director to lead Quality Data Analytics programs and enterprise analytics strategy across Quality functions. You will partner with senior leaders to embed data‑driven decision making throughout the medical device lifecycle and guide managers and teams toward scalable analytics and governance.

You will define analytics standards, drive CAPA and post‑market surveillance analytics, ensure regulatory readiness (FDA QSR/QMSR, ISO 13485, EU MDR, MDSAP), and lead

Qualifications

• Bachelor’s degree in Data Science, Engineering, Statistics, Quality, Computer Science, or related field.
• 12+ years of experience in data analytics or business intelligence.
• 7+ years of people leadership experience, including managing managers or large teams.
• Strong knowledge and expertise in Quality Management Systems and regulatory standards.
• Experience supporting regulatory inspections and audits.
• Experience in the medical device industry.
• Experience leading enterprise programs and portfolios.
• Proficiency in SQL and data visualization tools (e.g. Power BI, Tableau).
• Strong executive communication and stakeholder influence skills.
• Strong program/project management expertise.
• Ability to travel up to 25% if needed.

Responsibilities

• Define and execute the enterprise Quality Data Analytics strategy aligned with enterprise priorities.
• Lead and develop a team of analytics professionals and project/program manager, ensuring strong capability development and succession planning.
• Establish standards for analytics, reporting, and data governance across Quality functions.
• Oversee analytics supporting CAPA, complaints, audits, nonconformances, supplier quality, post‑market surveillance and other attributes and characteristics of our process and products that are Critical to Quality or associated with the Cost of Poor Quality.
• Ensure analytics outputs meet regulatory requirements (FDA QSR/QMSR, ISO 13485, EU MDR, and MDSAP, at minimum).
• Serve as a key leader during regulatory inspections, owning analytics narratives and data defensibility.
• Drive cross-functional collaboration across Quality, Regulatory, Manufacturing, and IT.
• Drive continuous improvement, automation, and adoption of advanced analytics techniques.
• Establish program management frameworks, governance, and reporting standards.
• Manage prioritization across multiple stakeholders and enterprise demands; and,
• Other duties as assigned.
• Supporting development and execution of the Program Management strategy.
• Leading a portfolio of strategic Quality programs and projects.

Skills

SQL

Power BI

Tableau

Leadership

Regulatory knowledge

Data analytics

Stakeholder management

Communication

Education

Bachelor’s degree in Data Science or related field

Tools

Power BI

Tableau

Job description

Integra LifeSciences seeks a seasoned Director to lead Quality Data Analytics programs and enterprise analytics strategy across Quality functions. You will partner with senior leaders to embed data‑driven decision making throughout the medical device lifecycle and guide managers and teams toward scalable analytics and governance.

You will define analytics standards, drive CAPA and post‑market surveillance analytics, ensure regulatory readiness (FDA QSR/QMSR, ISO 13485, EU MDR, MDSAP), and lead