Medical Device Complaint Trends Lead

Integra LifeSciences Corporation; Princeton (NJ); On-site; USD 82,000 - 113,000; Full time

Job summary

Integra LifeSciences Corporation seeks a Medical Device Complaint Trending Expert to lead end‑to‑end data trending, signal detection, and risk assessment across products and geographies. You will partner with Quality, Regulatory, Risk, R&D, Manufacturing, and Medical Safety to turn insights into CAPAs and regulatory submissions.

The role demands deep knowledge of FDA/EU MDR/ISO standards, strong analytics, and the ability to present findings to leadership.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biostatistics, Data Analytics, or a related field.
• 5–8 years in medical device quality, complaint handling, post-market surveillance, or safety analytics.
• Demonstrated expertise in complaint trending and signal detection.
• Strong knowledge of global medical device regulations (FDA, EU MDR, ISO standards).
• Advanced analytical and problem-solving skills with data interpretation.
• Proficiency with statistical software or data visualization tools.

Responsibilities

• Work end to end complaint trending data and analysis.
• Identify trends, distinguishing variation from signals.
• Design and improve complaint trending methodologies with regulatory alignment.
• Perform routine and ad hoc trending analyses for signals and risks.
• Apply statistical tools and visualization across products, failure modes, geographies.
• Establish alert thresholds and signal validation processes.
• Support inspections/audits with defensible trending analyses.
• Author/review SOPs and templates related to trending and post-market surveillance.
• Partner with Quality, CAPA, Risk Management to translate trends into investigations.
• Collaborate with Medical Safety, Clinical, Regulatory teams on safety impact.
• Present trending results to management and governance boards.
• Serve as SME for complaint data systems and analytics tools.

Skills

Statistical trending

Signal detection

Data visualization

CAPA familiarity

Regulatory knowledge

Leadership presentation

Education

Bachelor's degree in Engineering, Life Sciences, Biostatistics, Data Analytics, or related field

Tools

Minitab

Power BI

Oracle

TrackWise

Job description

Integra LifeSciences Corporation seeks a Medical Device Complaint Trending Expert to lead end‑to‑end data trending, signal detection, and risk assessment across products and geographies. You will partner with Quality, Regulatory, Risk, R&D, Manufacturing, and Medical Safety to turn insights into CAPAs and regulatory submissions.

The role demands deep knowledge of FDA/EU MDR/ISO standards, strong analytics, and the ability to present findings to leadership.