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Summary
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.
- ssists in benchmarking best practices with world-class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics.
- 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.
- udit 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.
- Ensures standard PMS processes across business unit is established.
- ssures consistent PMS plans exists for all products.
- ssures 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).
- ssures 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.
- ssesses 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.
- 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 complaint
- ssures standard regulatory reporting assessment criteria for PMS activities
- Provides 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.
- Support standard Risk Management processes
- Facilitate 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.
- Represent PMS interests in multi-disciplinary teams during product development.
- ssures 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.
- Post-Market Surveillance Mechanisms.
- Quality Management Systems (QMS).
- Regulatory Requirements.
- Technical Documentation.
- Project Management.
- Quality Assurance (QA).
- Data Management.
- Business Acumen.
-
Job Description
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.
- ssists in benchmarking best practices with world-class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics.
- 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.
- udit 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.
- Ensures standard PMS processes across business unit is established.
- ssures consistent PMS plans exists for all products.
- ssures 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).
- ssures 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.
- ssesses 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.
- 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 complaint
- ssures standard regulatory reporting assessment criteria for PMS activities
- Provides 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.
- Support standard Risk Management processes
- Facilitate 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.
- Represent PMS interests in multi-disciplinary teams during product development.
- ssures 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.
- Post-Market Surveillance Mechanisms.
- Quality Management Systems (QMS).
- Regulatory Requirements.
- Technical Documentation.
- Project Management.
- Quality Assurance (QA).
- Data Management.
- Business Acumen.
-
ABOUT THE COMPANY
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