Medical Device Complaint Trending Expert

Integra LifeSciences•Princeton, FL

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Medical Device Complaint Trending Expert is responsible for the end-to-end development, execution, and oversight of complaint data trending and signal detection activities to ensure timely identification of product quality, safety, and compliance risks. This role serves as a subject matter expert (SME) for complaint analytics, statistical trending methodologies, and regulatory expectations related to post-market surveillance. The individual partners cross functionally with Quality, Regulatory Affairs, Risk Management, R&D, Manufacturing, and Medical Safety to translate complex complaint data into actionable insights that support corrective and preventive actions (CAPA), regulatory submissions, and risk management decisions.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Biostatistics, Data Analytics, or a related field
Minimum 5–8 years of experience in medical device quality, complaint handling, post-market surveillance, or safety analytics
Demonstrated expertise in complaint trending, signal detection, and root cause analysis
Strong knowledge of global medical device regulations (FDA, EU MDR, ISO standards)
Advanced analytical and problem-solving skills with the ability to interpret complex data
Excellent written and verbal communication skills
Strong knowledge of global medical device regulations 21 CFR Parts 803 and 820 / QSR and QMSR EU MDR (Articles 83-86) MDSAP and ISO 13485 ISO 13485 and 14971
Experience presenting to internal leadership as well as regulators/auditors.
Strong oral and written communication skills and effective interpersonal skills.
Experience in FDA-regulated environment.
Strong collaboration skills and experience working in a matrix environment.
Ability to multitask, prioritize and meet deadlines.
Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.) is required.

Nice To Haves

Advanced degree (MS, MBA, or equivalent).
Proficiency with statistical software or data visualization tools (e.g., Minitab, Power BI, Oracle, TrackWise)
Experience working with global complaint databases and high-volume product portfolios

Responsibilities

Design, maintain, and continuously improve complaint trending methodologies aligned with regulatory and business risk principles
Perform routine and ad hoc trending analyses to identify statistically significant signals, emerging risks, and adverse trends
Apply appropriate statistical tools and data visualization techniques to evaluate complaint data across products, failure modes, and geographies
Establish alert thresholds, escalation criteria, and signal validation processes
Support inspections, and audits with defensible trending analyses and documentation
Author or review SOPs, work instructions, and templates related to trending and post-market surveillance
Partner with Complaint Handling, CAPA, and Risk Management teams to translate trend signals into formal investigations and actions
Collaborate with Medical Safety, Clinical, and Regulatory teams to evaluate patient safety and reporting impact
Present trending results and risk assessments to management, governance boards, and quality review councils
Serve as SME for complaint data systems and analytics tools (e.g., validated QMS systems, dashboards, and reporting platforms)
Ensure data integrity, consistency, and traceability across complaint datasets
Develop standardized dashboards, trend reports, and executive summaries
Interpret complex data sets and clearly communicate findings to both technical and non-technical stakeholders
Monitor industry best practices and regulatory guidance related to complaint trending and post-market surveillance
Identify process improvements to enhance early signal detection, efficiency, and compliance
Mentor and train colleagues on trending methodologies and regulatory rationale