Senior Clinician (United States)

Lead Clinician, Product Safety and Performance

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care. At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients. If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives.

The Lead Clinician, Product Safety and Performance is responsible for activities related to product safety surveillance and risk management, including review of data from clinical studies, literature reviews, complaints, regulatory reporting, product evaluations, statistical trending and potential safety issues. This individual reviews and prepares reports on aggregate data and provides recommendation for further escalation. Prepares Complaint Trend Analysis, product risk assessments including Health Hazard Evaluations, risk management documents and FMEAs. Assist in benchmarking best practices with world class organizations, interface with notified bodies, and/or other regulators and provide input to establish metrics. Interacts with internal and external manufacturing entities as Safety Surveillance representative.

Essential duties and responsibilities include:

• Provide guidance to Complaint Handling Analysts regarding investigation of product related events reported worldwide from patients, customers, sales reps and clinical studies/registries in order to assess product relationship to reported complaint.
• Contacts customers as needed.
• Code complaint files based on voice of customer information.
• Maintain and improve established coding guidelines to ensure consistency and accuracy with coding and reporting events.
• Compose clinical conclusion to be included in the reports to competent authorities around the world.
• Review of technical investigations and completeness of conclusions for returned product analysis for inclusion in Medical Device Reports.
• Evaluate and provide feedback; evaluate need for escalation.
• Review of weekly complaint report to identify any significant issues that need to be escalated or expedited.
• Develop malfunction code list and regulatory reporting tables in support of product launch activities (preparing surveillance system to capture data).
• Monitor customer complaint data for product quality trends.
• Generation and oversight of monthly statistical triggers.
• Review of monthly surveillance data to identify any significant triggers and provide an analysis of the triggered events to identify any safety concerns.
• Participate in monthly trending board meeting and provide input on actions taken for identified signals.
• Review/Approve Trend Analysis and make recommendations for further escalation when appropriate.
• Complete Distributed Product Risk Assessment Health Assessment portion and participate in Management Review discussions by providing surveillance data analysis and severity assessment per risk management documentation.
• Represent Quality Clinical interests in multi-disciplinary teams during product development.
• Perform clinical reviews and provide input of clinically related product risk issues during the development of the clinical portion of risk management documents such as FMEA's, Risk Management Plan, Risk Management Report and Clinical Evaluation Report in support of new product development and regulatory requirements.
• Perform clinical reviews and provide input to Health Hazard Evaluations for known quality issues under investigation.
• Evaluate and review of non-Clinical contributions to risk management documents such as FMEAs, Risk Management Plans, Risk Management Reports and Distributed Product Risk Assessments for conformance to procedure, completeness, content and accuracy.
• Ensure that safety surveillance operations activities supporting product release are efficient, effective and meet target timeframes from both a compliance and business perspective.
• Provide clinical complaint review as requested from regulatory bodies for individual complaints, annual reports or for certificate renewal.
• Provide education and training to employees worldwide about products, best practice to report complaints and return complaint products.
• Participate in site or global projects and improvement efforts, as needed.
• Participate in internal or external audits.
• Provides education and training of Cordis employees about clinical applications of Cordis products.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Required qualifications:

• Requires a minimum 8+ years of relevant experience with a Bachelor's degree; or equivalent education and experience; Or 6+ years and a Master's degree; Or a PhD with 3+ years experience; or equivalent experience.
• Where required, the role must hold an appropriate degree in the industry (eg. Legal).
• Must possess a Registered Nurse (RN) degree/ license.