Post market Surveillance Manager
Key areas of responsibility:
- Works with a variety of diverse persons within the company such as Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to perform PMS process
- Works together with Complaint Investigators during initial check/ reportability determination.
- Reviews complaints to ensure that all information needed for Reporting/Medical Device Reports in China (MDRs) is present; determines if further investigation is needed and tracks investigation to conclusion.
- Works together with PMS Team Leads to address Competent Authority inquiries and prepares the responses for such inquiries.
- Responsible for managing the Post-Market Surveillance process and the deliverables. Facilitate the creation of PMS plans and reports in accordance with written procedures and China Regulatory requirements。
- Organize PMS teams, to plan and gather all information needed for the creation of PMS reports and Plans.
- Support the identification of metrics on the efficacy and efficiency of PMS activities and monitor and report on those metrics.
- Supports the Correction and Removals process to ensure that risks and quality issues are timely and effectively addressed.
Organizationally you are part of the newly formed IGT Cluster R&D organization in Philips China
To succeed in this role you need:
- Management and strong leadership skills in a challenging working environment with a proven track record of 3+ years of experience in managing and transforming a large team
- Bachelor’s degree preferably in Engineering or Science
- 6+ years of related experience in a medical device or regulated industry preferably in post market surveillance, risk management, complaint handling, adverse event reporting and related processes.
- Good analytical skills and process improvement capabilities with the ability to resolve complex issues in creative and effective ways.
- Strong written and oral communications skills in English/Chinese
- High reliability and quality focus
- Advanced Excel skills
- Teamwork in and outside Q&R.
- Self-starter, High engagement, motivation and flexibility
- Project Management skills is and advantage
- Able to work in a changing environment and be a driver of change.
- In-depth knowledge of Quality management systems.
- In-depth knowledge of China Medical Regulations and working knowledge of appropriate global 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, C.
In return, we offer you
- We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:
- A market conform salary
- A variable bonus based on both Philips results and personal performance
- Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
- Solid company pension scheme and attractive collective health insurance package
- Opportunity to buy Philips shares and products with discount
- Healthy work-life balance
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 2.5 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.
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.
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
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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
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Working at Philips is more than a job. It's an experience filled with unexcepted moments that
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building a career that no one could have planned for. Even you.