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Job Information

Philips Post Market Surveillance Manager in Shenzhen, China

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In this role, you have the opportunity to

  • Lead team of investigators responsible to evaluate, investigate, and resolve complaints

  • Be contact person with EU authority representative and write MDV/adverse event report to the necessary authorities

You are responsible for

  • Lead team of investigators responsible to evaluate, investigate, and resolve complaints

  • Coordinate the periodic post-release product risk assessment

  • Prepare the MDV (NMPA form in post-release product surveillance system )

  • Contact person with EU Authority representative on incident/FSCA report

  • Works with a variety of diverse persons within the company such as Engineers, Field Service & Application Engineers and Manufacturing personnel to facilitate reportable device events in accordance with written procedures and global reporting requirements

  • Provides review of complaint to ensure all information needed for Reporting/MDRs is present; determine if further investigation is needed and track investigation to conclusion

  • Monitors and improves tracking/control systems for medical device reporting

  • Investigates and prepares response to address Competent Authority inquiries and provide follow-up

You are a part of

•Professional Post-market Surveillance Team, with around 10 team peers globally.

To succeed in this role, you should have the following skills and experience

•Education: Bachelor degree, major in science or engineering discipline is preferred.

•Experience: At least 5 years of Quality and/or Regulatory experience in medical related industries, experience in Post-market Surveillance is an advantage. At least 3 years of leading a team.

•Competencies and Skills:

•Good command of English and Chinese Language skill is required.

•Be familiar with ISO 13485, ISO 9001 and ISO 14971

•Be familiar with MDD 93/42/EEC or EU-MDR

•Excellent organization and coordination,

•Demonstrated strong results orientation.

•Must be able to work under pressure to meet regulatory reporting timeframe and company requirements.

•Be willing to work outside of normal working hours as needed to accommodate businesses in multiple time zones.

•Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

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