Regulatory Post Market Surveillance Adverse Event Analyst (clinical expertise)

Primary Function of Position:

The Regulatory Post Market Surveillance Adverse Event Analyst investigates customer complaints related to injury / adverse event / or death cases and makes reporting decisions, files regulatory reports, and ensures completeness and consistency of complaint documentation. This role includes live telephone intake and documentation of death and injury events phoned in to Intuitive by company representatives and customers.

Roles & Responsibilities:

• Investigating serious injury / adverse event and death complaints daily
• Perform the preliminary classification of complaints including reportability triage and decision making
• Conduct complaint investigations including following up with surgeons and other health care professionals via phone and email
• Perform reportability determinations in conjunction with medical safety officer, as necessary
• Provide input to clinical conclusion to be included in the complaint file and regulatory reports
• Escalate complaints that require additional review to engineering, medical safety officer, clinical development engineering, etc.
• Accurately select Risk (Hazard, Harms, Severity) and IMDRF codes
• Review product analysis investigation and determine cause / contribution of event to device
• Draft and file medical device and vigilance Reports
• Evaluate documentation for completeness and consistency
• Approve final complaint file for closure after all applicable actions are completed
• Manage complaint workload to required timeliness and goals
• Collaborate with internal teams including clinical development engineering, human factors, medical safety office, risk management, engineering, and other departments as needed to provide relevant and critical clinical information related to adverse events
• Adherence to standard operating procedures and guidance documents across the organization for reporting, investigation and compliance related to post market requirements
• Analyze complaint data to identify trends, issues, or systemic discrepancies
• Recognize and escalate trends and alert limits or process triggers of safety concerns to defined escalation path to communicate these concerns.
• Provide the risk management team required data to support and incorporate new failure modes into risk management files
• Collaborate with the Medical Safety Office to support monitoring activities and ensure timely escalations.
• Collaborate with the Intuitive Legal Department for legal claims
• Ensure compliance to post market surveillance processes for regulatory database searches, literature reviews, surveys, and other proactive surveillance
• Assess product relationship to reported complaints to root cause
• Align to standard regulatory reporting assessment criteria
• Complete responses for Regulatory Agency Requests for additional information as assigned
• Represent Post Market Surveillance at selected cross functional meetings
• Provide monthly, daily, weekly reporting of key metrics and action plans
• Drive the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint
• Participate in internal and external audits
• Develop and maintain product knowledge of existing and new products
• Maintain awareness of new or revised regulations and/or guidelines
• Provide peer review and feedback of complaints and reports
• Participate in new hire training and continuous Regulatory Compliance training as required
• Participate in process improvement activities to continuously improve process effectiveness
• Execute on projects as required
• Perform other duties as directed

Skills, Experience, Education, & Training:

Education - Minimum Undergraduate degree in life science (e.g. RN), engineering, or equivalent

Experience - Minimum 5+ years of experience in medical device field, with experience in the following areas:

• Working knowledge and understanding of the FDA 21 CFR part 803 Medical Device Reporting and part 820.198 for Complaint File management
• Global regulatory medical device requirements for EU, MDSAP countries, and other related requirements
• clinical expertise

Skills - The following skills are required for this position:

• Demonstrate strong written and verbal communication skills
• Strong computer skills (Excel, Word, PowerPoint, database query)
• Efficient independent worker with ability to focus
• Attention to detail
• Demonstrate cross functional communication skills in email and in person
• Strong analytical and Excellent organizational skills
• Ability to handle and manage workload independently
• Prioritize numerous activities in a rapid paced environment
• Contribute to team-oriented tasks
• Strong interpersonal and decision-making skills

Competency / Training - The following competencies are essential for this position:

• Firm understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements including good documentation practices and quality system elements.
• Firm understanding of quality records requirements and how they apply to complaint files.
• Familiarity with world-wide regulatory reporting requirements.
• Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.

Aviso sobre los Controles de Exportación de EE. UU.: De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR §743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportación de EE. UU. para candidatos que sean nacionales de países actualmente bajo embargo o sanciones.

Cierta información que usted proporcione como parte de la solicitud será utilizada para determinar si Intuitive Surgical necesitará (i) obtener una licencia de exportación del gobierno de EE. UU. en su nombre (nota: el proceso de obtención de la licencia puede tardar entre 3 y más de 6 meses) o (ii) implementar un Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) (nota: normalmente este paso agrega 2 semanas al proceso de contratación).
Para cualquier puesto en Intuitive sujeto a controles de exportación, las ofertas finales están condicionadas a la obtención de una licencia de exportación aprobada y/o a la ejecución de un TCP antes de la fecha de inicio del empleado potencial, la cual puede o no ser flexible, y dentro de un plazo que no obstaculice de manera irrazonable la necesidad de contratación. Si aplica, los candidatos serán notificados e instruidos sobre cualquier requisito relacionado con estos fines.