Post Market Surveillance - Risk Management Specialist
Post Market Surveillance - Risk Management Specialist (Randstad Contingent Worker)
This position will be fully remote and can be home-based from anywhere in the US. However, the work hours will align to EST time zone.
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, and other key
Post Market Surveillance (PMS)
• Ensuring standard PMS processes across business units
• Assuring consistent PMS plans exists for all products
• Assuring 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 across business units
Patient Safety and Regulatory Reporting
• In collaboration with Medical Affairs, monitors and assesses safety signals, and recommends actions
• Assesses product relationship to reported complaint.
• Assures standard regulatory reporting assessment criteria
• Provides input to clinical conclusion to be included in the reports to competent authorities
• Support standard RM processes
• In collaboration with stakeholders, defines standard risk acceptability criteria (RAC) with stakeholders
• Supports the development of consistent RM plans exists for all products
• Assures consistent RM plans exists for all products
• Provides oversight and clinical guidance on risk assessments including post-market risk assessments and health hazard evaluations
PMS and RM Governance
• Assures standard PMS and RM governance across Business Units
• Provides oversight of PMS and RM processes and assures standard approach
• Signal Assessment & Escalation:
o Ensures standard statistical trending techniques
o Assesses significant triggers & safety concerns.
o Manage recurrent PMS/RM data review meetings
o Assures standard approach for signal disposition
o Incorporate findings in PMS reports and updated RM files as required
PMS and RM input into Product Development
• Represent PMS interests in multi-disciplinary teams during product development.
• Assures development and completion of PMS & RM deliverables throughout the design process
• Provides input of PMS related product risk & quality issues during the development of new products
To succeed in this role, you should have the following skills and experience:
• Bachelor’s degree in health science or similar healthcare-related field, such as Medical Doctor MD, Nursing, Radiology, Registered Pharmacist (RPH) , or equivalent (4 year degree required; additional education is desirable)
• 6-8 years of experience in the pharmaceutical / medical device industry or direct device clinical experience
• Regulatory Affairs, Quality Assurance, or Complaint Handling experience in pharmaceuticals or medical devices
• Demonstrates collaborative patient and customer focus
• Direct experience/knowledge of most regulations relative to PMS activities and reporting, such as: ISO 13485/14971, FDA Regulations (21CFR (803, 806, 82, etc.)), CMDR, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), and EU MDR is preferred.
• Experience interacting with the FDA, ISO, and Other Regulatory Authorities preferred
• English proficiency oral and written must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate.
• Excellent communications and analytical skills
• Project management skills preferred
• In depth knowledge of medical terminology preferred
• Understanding of statistical fundamentals is preferred
• Experience with health hazard evaluations is preferred
• Extensive hands-on experience with the ISO 14971 standard.
• Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.
• Strong 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 preferred.
• Excellent team work skills including influencing and building rapport with internal customers and stakeholders.
You will be a part of:
An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.
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.