Lead Clinician - Product Safety and Performance

Cordis • Miami Lakes, FL

1d

About The Position

The Lead Clinician, Product Safety and Performance is responsible for product safety surveillance and risk management. The role reviews data from clinical studies, literature reviews, complaints, regulatory reporting, product evaluations, statistical trending, and potential safety issues. The Lead Clinician reviews and prepares aggregate data reports and recommends further escalation. The role also prepares Complaint Trend Analyses, product risk assessments including Health Hazard Evaluations, risk management documents, and FMEAs. It assists with benchmarking best practices, interfaces with notified bodies and other regulators, provides input to establish metrics, and interacts with internal and external manufacturing entities as a Safety Surveillance representative.

The position provides clinical input across complaint handling, regulatory reporting, trend analysis, product risk management, and product development. It guides Complaint Handling Analysts, reviews investigations and surveillance data, supports regulatory submissions and audits, and provides education and training to employees worldwide. The role ensures safety surveillance operations supporting product release are effective, efficient, compliant, and meet target timeframes.

Requirements

• Minimum 8+ years of relevant experience with a bachelor's degree, or equivalent education and experience; alternatively, 6+ years with a master's degree, or a PhD with 3+ years of experience, or equivalent experience.
• Must possess a Registered Nurse (RN) degree/license.
• Where required, must hold an appropriate degree in the industry (for example, legal).

Responsibilities

• Provide guidance to Complaint Handling Analysts investigating product-related events reported worldwide and assess the relationship between products and reported complaints; contact customers as needed.
• Code complaint files using voice-of-customer information.
• Maintain and improve coding guidelines to support consistent and accurate coding and reporting of events.
• Compose clinical conclusions for reports submitted to competent authorities worldwide.
• Review technical investigations and returned-product analysis conclusions for completeness and inclusion in Medical Device Reports; provide feedback and assess escalation needs.
• Review weekly complaint reports to identify significant issues requiring escalation or expedited handling.
• Develop malfunction code lists and regulatory reporting tables for product launches.
• Monitor customer complaint data for product-quality trends.
• Generate and oversee monthly statistical triggers.
• Review monthly surveillance data, analyze triggered events, and identify potential safety concerns.
• Participate in monthly trending board meetings and provide input on actions taken for identified signals.
• Review and approve Trend Analyses and recommend further escalation when appropriate.
• Complete the Health Assessment portion of Distributed Product Risk Assessments and participate in Management Review discussions by providing surveillance data analysis and severity assessments.
• Represent Quality Clinical interests on multidisciplinary product-development teams.
• Conduct clinical reviews and provide input on clinically related product risks and clinical portions of risk management documents, including FMEAs, Risk Management Plans, Risk Management Reports, and Clinical Evaluation Reports.
• Conduct clinical reviews and provide input to Health Hazard Evaluations for known quality issues under investigation.
• Review non-clinical contributions to risk management documents and Distributed Product Risk Assessments for procedural conformance, completeness, content, and accuracy.
• Ensure safety surveillance operations supporting product release are efficient, effective, compliant, and meet target timeframes.
• Provide clinical complaint reviews requested by regulatory bodies for individual complaints, annual reports, or certificate renewals.
• Educate and train employees worldwide on products, complaint-reporting best practices, and returning complaint products.
• Participate in site or global projects and improvement efforts as needed.
• Participate in internal or external audits.
• Educate and train Cordis employees about clinical applications of Cordis products.
• Ensure personal and Company compliance with applicable federal, state, local, and Company regulations, policies, and procedures.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior