Sr. Clinical Post Market Specialist
In this role, you have the opportunity to
In this role you will support post market activities and other quality tasks for the Hospital Respiratory Care business unit. These activities focus on the process for global medical device reporting to competent authorities and includes review and evaluation quality complaints for fielded product which may represent reports of adverse events and/or critical device malfunctions and timely processing of the reports required for compliance to global regulations and standards. The role further supports general post market surveillance activities including timely closure of complaint records, process optimization, data analytics, and the development and implementation of solutions to meet the changing needs of a dynamic regulatory environment.
You are responsible for
- Support the global medical device reporting process for the Hospital Respiratory Care business by completing the following:
- Performing initial review of complaint records to determine if reports represent information which may be reportable to one or more global competent authorities
- Identifying complaints that may be reportable as adverse events or those needing further review or investigation
- Completing detailed adverse event reporting decisions including detailed evaluation of device malfunctions and reported patient outcomes
- Investigate and document specific elements and circumstances involved in a complaint. Critical elements of the complaint recorded
- Assess accuracy and completeness of service findings and associated coding. Working with domestic and international service organizations to resolve open issues.
- Support closure of quality and non-quality complaints
- Working with customers, sales & marketing, engineers and others to investigate and address customer and regulatory inquiries
- Preparing and filing written response to competent authority inquiries. All responses will be completed and filed within the time period specified by the requesting agency
- Perform other QA related duties on an as needed basis to support department objectives and business needs
- Consistently apply established device Risk Management File decisions individual complaint investigations for medical devices. Identify and escalate issues not represented in established Risk Management Files
- Complaint Handling with focus on Clinical Review in accordance with global regulations and standards.
- Identify and escalate issues potentially impact Risk Management Files. Support a quality culture of continuous improvement
You are 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’ll find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It’s 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.
To succeed in this role, you should have the following skills and experience
- Bachelor's degree OR relevant two-year degree with 6+ years working in a health related position.
- Licensed Respiratory Therapist or Registered Nurse with 2+ years working in a clinical environment.
- Demonstrated familiarity with statistical analysis concepts and techniques, quality methods, tools, and concepts.
- Demonstrated, excellent analytical, investigative and writing skills.
- Medical device/Life Science Industry experience with familiarity in quality complaint handling and Quality Management Systems.
- Experience interfacing directly with FDA or other regulatory agencies is preferred.
- Experience in conducting complaint investigations including adverse event reporting in a global environment.
In return, we offer you
The opportunity to be part of an organization that is committed to touching 3 billion lives worldwide. The opportunity to use your skills to support products which provide lifesaving diagnostics and therapy. A chance to grow your professional skills in an environment that values diverse ideas and creative approaches.
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 improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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