Post Market Surveillance Specialist

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 complaint
- Assures 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.

- 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.