Post Market Surveillance Consultant
Post Market Surveillance Consultant (Randstad Contingent Worker)
This role will be fully remote and can be based anywhere in the US.
In this role, you will have the opportunity to:
Be a key developer in expanding our Quality & Regulatory Risk Management team for our Connected Care organization. Create and implement new tools and methods to manage risk, which will contribute to the safety and efficacy of medical products that save lives and improve health.
You will be responsible for:
Collaborate at a systems level with R&D, Clinical, Data Analysis, complaint handling and other key functions to assess product safety post launch by (supporting the following areas:) (Owning the following tasks) (Leading and delegating the following task to ensure adherence to standards, regulations and internal risk management and post market processes). As a risk manager you will be responsible to (assist, own or lead) the deliverable of the following documents
Post Market Surveillance Plan, PMSP:
• Contribute to the creation and deployment of all required PMS plans
• Assist in the creation and release of all required PMS plans by conducting adverse event searches in medical databases for similar or compatible devices
• With the assistance of other risk managers create, own and release PMS plan(s)
• Ensure all post market activities are documented within each PMS plan
• Ensure PMS plans for every supported product exists and is readily available
• Collaborate with the respective HPM’s BPO in making and deploying post market process updates to improve the layout and content of PMS templates
Post Market Surveillance Report:
• Assist in the creation of EU MDR, Canada and China required post market reports such as Periodic Safety Update Report, Post Market Surveillance Report, Periodic Product Risk Evaluation Report, and the Canada post market report.
• Assist other RM by creating and owning the PQRR and PSRR
• Generate a PQRR or PSRR with minimal assistance / supervision
• Create and own the PMSR, PSUR, PPRER or Canada report
• Complete required analysis for Reports
• Define the cadence to review / update owned PMS plans and / or post market reports
• Assist other RM in updating or reviewing other post market reports
• Assess product safety and efficacy by using known statistical technics to identify and address negative trends
• Trigger and if required own IIA stemming from post market reports
• Collaborate with NPI RM and product PQE to improve current or future products by analyzing and trending post market data
• Release reports in respective PLM databases (ie Windchill, eDMR)
Risk Management activities and processes:
• Complete a risk assessment for all reportable complaints
• Assist in updates or edits to the RMM
• Assist other RM in creating or updating the Risk Management Plan and Report
• Assist in reviewing and maintaining the post market failure codes and evaluation and investigation tables
• Determine and recommend the P1, P2 and PoH values based on historical post market reports
• Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips’ procedures
• Support ongoing compliance improvement initiatives, including CAPAs across the five business groups in Connected Care
• Support standard RM processes based PEPF 16.2.12 Risk Management deployed in to local QMS
To succeed in this role, you should have the following skills and experience:
• Bachelor of Science in Engineering or a related field.
• 5+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry.
• Familiarity with the ISO 14971 standard is preferred but not required
• Awareness of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.
• Basic understanding of risk management requirements, tools, methodologies, and processes, including use of a variety of accepted methods.
• Demonstrated expertise in managing complex projects and implementing cultural change.
• Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of peers and leadership.
• Experience working within a Quality Management System.
• Green Belt or Black Belt certification are preferred but not required.
• Excellent teamwork skills including influencing and building rapport with internal customers and stakeholders.
• Ability to work well independently and in a collaborative environment
• Learn concepts quickly and engage in work tasks without consistent oversight
• Well organized and able to multitask to complete on multiple deliverables
You will be a part of:
The Connected Care (CC) Business is a global health technology leader in Hospital Patient Monitoring, Emergency Care, Sleep and Respiratory Care, EMR & Care Management, Ambulatory Patient Monitoring and Clinical Data Services. By advancing connected care, we seamlessly connect patients and caregivers across care settings, delivering clinical, operational and therapeutic solutions that improve health outcomes, patient and staff experience and lower costs.
In return, we offer you:
Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.
Quality is on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Why work on a project at Philips?
If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.
The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.