Post Market Surveillance Specialist

Katalyst CRO; Bothell (WA); In loco; USD 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO seeks a PMS Specialist to manage post-market product safety surveillance and risk management initiatives. You will coordinate PMS plans, reports, and PSURs while driving CAPAs and ensuring regulatory alignment across FDA/EU-MDR environments.

The role requires 4–5 years in post-market surveillance, strong regulatory knowledge, and cross-functional collaboration with Medical Affairs, R&D, Services, and Complaint Handling. Expect a compliance-focused, fast-paced work setting.

Competenze

• Bachelor's degree or equivalent required with focus on post-market surveillance and regulatory compliance.
• 4–5 years' experience in Post Market Surveillance within FDA/EU-MDR regulated Medical Device environments; proficiency in PMS plans/reports and risk assessment.
• Knowledge of medical device regulations and standards (e.g., 21 CFR Parts 803, 806, 820; ISO 13485; ISO 14971; EU MDR; CanadianRegulations).

Mansioni

• Manage activities related to post-market product safety surveillance and risk management including PMS plans and reports.
• Conduct Periodic Quality Review Board meetings and create Periodic Quality Review Reports.
• Prepare and update PSURs and provide CAPA ownership for PMS.
• Audit and inspection support and regulatory reporting input.
• Collaborate with cross-functional stakeholders to drive post-market risk assessment of issues.

Conoscenze

Post-Market Surveillance

Regulatory knowledge

CAPA ownership

Risk assessment

Data analysis

Cross-functional collaboration

Project management

Formazione

Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent

Descrizione del lavoro

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.