Job Description You are responsible for managing activities related to post-market product safety surveillance and risk management.Serves as a liaison between Medical Affairs, Clinical Affairs, Research & Development, Services, and Complaint Handling to ensure Post Market Surveillance (PMS) and Risk Management (RM) processes are executed end-to-end (E2E).Reviews and prepares reports on aggregate data and provides recommendation for further escalation.Prepare/review complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs.Assists in benchmarking best practices with world-class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics.Responsibilities The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including:Creation and maintenance of PMS Plans.Creation and maintenance of PMS Reports.Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports.Preparation and update of PSURs.Audit and Inspection support.Own and effectively drive CAPAs on post-market surveillance.Facilitate Post Market Risk Assessment including Issue impact assessments, Health hazard evaluation, etc.Post Market Surveillance (PMS) Ensures standard PMS processes across business unit is established.Assures consistent PMS plans exists for all products.Assures consistent and standard process exists to perform proactive surveillance (e.g. regulatory database searches, literature reviews) and reactive surveillance (e.g. complaints handling, field actions).Assures consistent PMS Reports/PSURs for all products.Conduct periodic quality board meeting to review PMS data collected according to the PMS plan and take appropriate actions as necessary to ensure the product remains safe and compliant.support Complaint trending investigation, signal assessment & escalation.Assesses significant triggers & safety concerns during periodic quality review meeting and assures standard approach for signal disposition; incorporate findings in PMS reports and trigger risk management file update, as required.Patient Safety And Regulatory Reporting In collaboration with Data trending and analytics and Medical Affairs, monitors and assesses safety signals, and recommends actions.Support in assessment of product relationship to reported complaintAssures standard regulatory reporting assessment criteria for PMS activitiesProvides input to clinical conclusion to be included in the reports to competent authorities.Enable correction & removal decision making by facilitating on time and accurate post market risk assessments.Risk Management Support standard Risk Management processesFacilitate post-market risk assessments including issue impact assessment, health hazard evaluations.Collaborate with cross-functional stakeholders including R&D, Services, Complaint handling, Medical Affairs, Clinical Affairs, Engineering, etc. to drive meaningful post market risk assessment of issues.Support the preparation and/or review of Risk management documents including risk management plans, risk matrix status reports, PPMRR, etc.PMS And RM Input Into Product Development Represent PMS interests in multi-disciplinary teams during product development.Assures development and completion of PMS deliverables throughout the design process.Provides input of PMS related product risk & quality issues during the development of new products.Requirements:Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.Minimum of 4-5 years' experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments with a focus on post-market surveillance plans/reports and post market risk assessment.Knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc.You have 4-8 years' experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments with a focus on post-market surveillance plans/reports and post market risk assessment Mandatory.You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc Mandatory.Preferred Skills Post-Market Surveillance Mechanisms.Quality Management Systems (QMS).Regulatory Requirements.Technical Documentation.Project Management.Quality Assurance (QA).Data Management.Business Acumen.#J-18808-Ljbffr
Job Description You are responsible for managing activities related to post-market product safety surveillance and risk management.Serves as a liaison between Medical Affairs, Clinical Affairs, Research & Development, Services, and Complaint Handling to ensure Post Market Surveillance (PMS) and Risk Management (RM) processes are executed end-to-end (E2E).Reviews and prepares reports on aggregate data and provides recommendation for further escalation.Prepare/review complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs.Assists in benchmarking best practices with world-class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics.Responsibilities The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including:Creation and maintenance of PMS Plans.Creation and maintenance of PMS Reports.Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports.Preparation and update of PSURs.Audit and Inspection support.Own and effectively drive CAPAs on post-market surveillance.Facilitate Post Market Risk Assessment including Issue impact assessments, Health hazard evaluation, etc.Post Market Surveillance (PMS) Ensures standard PMS processes across business unit is established.Assures consistent PMS plans exists for all products.Assures consistent and standard process exists to perform proactive surveillance (e.g. regulatory database searches, literature reviews) and reactive surveillance (e.g. complaints handling, field actions).Assures consistent PMS Reports/PSURs for all products.Conduct periodic quality board meeting to review PMS data collected according to the PMS plan and take appropriate actions as necessary to ensure the product remains safe and compliant.support Complaint trending investigation, signal assessment & escalation.Assesses significant triggers & safety concerns during periodic quality review meeting and assures standard approach for signal disposition; incorporate findings in PMS reports and trigger risk management file update, as required.Patient Safety And Regulatory Reporting In collaboration with Data trending and analytics and Medical Affairs, monitors and assesses safety signals, and recommends actions.Support in assessment of product relationship to reported complaintAssures standard regulatory reporting assessment criteria for PMS activitiesProvides input to clinical conclusion to be included in the reports to competent authorities.Enable correction & removal decision making by facilitating on time and accurate post market risk assessments.Risk Management Support standard Risk Management processesFacilitate post-market risk assessments including issue impact assessment, health hazard evaluations.Collaborate with cross-functional stakeholders including R&D, Services, Complaint handling, Medical Affairs, Clinical Affairs, Engineering, etc. to drive meaningful post market risk assessment of issues.Support the preparation and/or review of Risk management documents including risk management plans, risk matrix status reports, PPMRR, etc.PMS And RM Input Into Product Development Represent PMS interests in multi-disciplinary teams during product development.Assures development and completion of PMS deliverables throughout the design process.Provides input of PMS related product risk & quality issues during the development of new products.Requirements:Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.Minimum of 4-5 years' experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments with a focus on post-market surveillance plans/reports and post market risk assessment.Knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc.You have 4-8 years' experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments with a focus on post-market surveillance plans/reports and post market risk assessment Mandatory.You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc Mandatory.Preferred Skills Post-Market Surveillance Mechanisms.Quality Management Systems (QMS).Regulatory Requirements.Technical Documentation.Project Management.Quality Assurance (QA).Data Management.Business Acumen.#J-18808-Ljbffr
