Post Market Surveillance (PMS) Specialist

The Post Market Surveillance (PMS) Specialist is a key member of the DXR Quality team and serves as a subject matter expert to support all aspects of Post-Market Surveillance.

Key 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.

Your role:

• 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.

Post Market Surveillance (PMS)

• Ensures standard PMS processes across business unit is established
• Assures consistent PMS plans exists for all products
• Assure 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).
• Assure 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.

You're the right fit if:

• You have a minimum of Bachelor's degree in Life Sciences, Biomedical Engineering, or a related technical field.
• 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
• You have excellent communication (written and oral) and stakeholder management skills, with the ability to influence at all levels.
• You have a passion for simplification and optimizing processes and workflows, identifying opportunities for automation and software tools that improve productivity, quality and compliance.
• Product Knowledge on Diagnostic X-rays is preferred.

In return, we offer you

At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy, respiratory care and services.

How we work at Philips

Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:

We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.

We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.

We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.