Clinical Complaint Specialist
Position: Clinical Complaint Specialist
Location: Shenzhen Preferred or Other Cities of China (China-Remote Base)
In this role, you have the opportunity to
- Work in the medical industry on life-saving devices brings much fulfillment, as well as unique challenges. As part of our HealthTech-focused company, you will be responsible for successfully managing issues directly affecting the safety and effectiveness of our devices, as well as Philips’ compliance status with regulatory agencies such as the US Federal Drug Administration (FDA).
- Reviewing all clinical complaint information to fully understand the sequence of events and patient outcomes – including detailed analysis of clinical event files, ECG strips, and reported clinical use details to evaluate for normal device behavior, evidence of malfunction or user issue, unexplained behavior, and to provide a summary of the device behavior for the complaint investigation.
- Managing the acquisition and review of all clinically related complaint information for adverse patient events, non-adverse patient events, and ad hoc requests related to device functionality and clinical practice.
- Consulting with subject matter experts (SME) as needed to understand unexpected or abnormal device behavior (R&D, algorithm engineers, other clinical experts).
- Developing/maintaining comprehensive understanding of each of the ALS hospital and prehospital defibrillator devices and their accessories (including similarities and differences), including shock advisoryand ECG algorithms.
- Understanding of AHA/ERC/ILCOR resuscitation guidelines; understanding differences in US/OUS practice and use models.
- Supporting the complaints team with on-time vigilance reporting for all clinically related complaints; understanding of regional timeline and other requirements for Death/Serious Injury complaints
- Maintaining compliance with all complaint investigation processes and requirements.
- Contributing to customer letter development describing the findings of complaint investigations and device behavior as requested to include consideration and incorporation of feedback from legal representative.
- Collaborating with and mentoring of complaint investigators to produce a compliant, comprehensive and well written complaint investigation.
- Escalating critical clinical events to the business (manager, etc.) to allow for rapid business response as needed.
- Developing expertise with Event Review Pro software for review of defibrillator events
- Participating in clinically related business meetings as required.
- Supporting reviews and audits assigned.
You are a part of
- A passionate and enthusiastic Medical Office team committed to providing the very best service to customers. More broadly you will be working as part of the Philips Healthcare team and have daily interactions with internal and external stakeholders across the business, especially the Research & Development, Clinical Science, Sales and Product Management teams.
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree or above, major in Clinical medicine, Biology Medical Engineering, Nursing related discipline.
- At least 5 yrs. Experience in Critical care in hospital in clinical science related roles such as RN, Physician’s Assistant (PA) or Nurse Practitioner (APRN) for EMS experience (familiar with Medical Device -Patient Monitoring including Monitor/Defibrillators and/or AEDs.)
- Active RN or Paramedic licensure required
- In-depth clinical experience with Resuscitation
- Fluency in English & Chinese required
- Previous experience in presentations and training
- Outstanding relationship building and communication skills
- High levels of motivation, energy and a drive to achieve results
- Desire to work in dynamic, cross-functional teams to support customers
In return, we offer you
- The work we do at Philips changes lives for the better. It’s not just innovation for the sake of innovation. It’s innovation for the sake of people. For us, it’s about helping communities everywhere and addressing the big issues head on.
- We offer a competitive salary, on-going training and development opportunities, outstanding benefits and flexibility in a career with a positive and supportive atmosphere in which to develop your talents further.
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. Learn more by watching this video.
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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven.
Little did they realize that it would become a global force of innovation, committed to
improving billions of lives worldwide. But it did.
Today, Philips is a world leading health technology company with a vision to make life better
for people worldwide through meaningful innovation. Making good on this promise depends on our
passionate, inspirational, collaborative and diverse team.
We have over 80,000+ brilliant people around the world but are always looking for more.
Like-minded, motivated, focused minds to join us in creating a healthier, more connected society
while tranforming themselves personally and professionally.
Working at Philips is more than a job. It's an experience filled with unexcepted moments that
will transform you in lasting and positive ways. Help us improve the world for the better while
building a career that no one could have planned for. Even you.