Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, or equivalent.
4-5 years' experience in Post Market Surveillance in FDA/EU-MDR regulated environments.
Knowledge of medical device regulations and standards (21 CFR, ISO 13485, EU MDR, etc.).
Detailed understanding of post-market surveillance plans and risk management processes.
Preferred skills include experience in Quality Management Systems (QMS) and project management.
Responsibilities
Manage post-market product safety surveillance and risk management activities.
Create and maintain PMS Plans and Reports.
Conduct Periodic Quality Review Board Meetings and draft related reports.
Prepare and update Periodic Safety Update Reports (PSURs).
Support audits and inspections, ensuring compliance.
Drive corrective and preventative actions (CAPAs) related to post-market surveillance.
Facilitate post-market risk assessments and evaluations.
Benefits
Collaborative work environment across multiple departments.
Opportunity to benchmark best practices with world-class organizations.
Gaining insights into regulatory bodies and compliance processes.
Involvement in the product development lifecycle including risk assessment.
Potential professional development opportunities in medical device regulations.
Full 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.
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.
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.
Post Market Surveillance (PMS):
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.
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 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.
Risk Management:
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.
PMS and RM input into Product Development:
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.
