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olutions across the <a href="https://www.philips.com/b-dam/corporate/corporateblog/2016/Philips_Chronic_Disease_5.jpg" target="_blank">health continuum </a>. Our people experie
lso learn about our <a href="https://www.careers.philips.com/global/en/recruitmentprocess" target="_blank">recruitment process </a>, or find answers to
some of the <a href="https://www.careers.philips.com/global/en/faq" target="_blank">frequently asked questions </a>. </p><p></p></body></html>
ways. Learn more by <a href="https://youtu.be/ocnMFp1JBuM" target="_blank">watching this video </a>. </p><p></p><p>To find out mor
ad stories from our <a href="https://www.careers.philips.com/global/en/blog" target="_blank">employee blog </a>. Once there,you can
al level, visit the <a href="https://www.careers.philips.com/professional/global/en/workingatphilips" target="_blank">Working at Philips page </a> on our career websi

Job Information

Philips Q&R- Post Market Surveillance Specialist in Sydney, Australia

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In this role, you have the opportunity to improve and maintain business regulatory compliance and as well as enhancing customer satisfaction. Executing the implementation and maintenance of on-going post market surveillance activities within Philips Health Tech. Be responsible for providing regular status reports to Management and Regulatory Authorities as required.

You are responsible for

  • Maintain and improve tracking tools / reports to monitor metrics and trends

  • Collect, review, track, trend, analyse and report on complaint data generated from the adverse events & field actions to create periodic reports

  • Drive identification of trends and signals

  • Execute post market product data analysis to provide information on field product quality

  • Lead the post market surveillance reporting activities

  • Generate reports to support business needs

  • Lead the field action execution, reconciliation and data analysis

  • Assist with complaint administration tasks as required

  • Review adverse event report and submission to regulators

  • Identify and drive implementation process improvements

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

  • Bachelor Degree in Engineering/Science with 2/3 years of working within complaints/ post market surveillance in a

  • Medical device environment.

  • 2/3 years experience in vigilance reporting – essential

  • Excellent technical writing experience within a medical device environment – essential

  • Has full understanding of ISO9001, ISO 13485, FDA QSR, local ANZ laws.

  • Experience with Competent Authority medical device regulations especially with the TGA/ Medsafe – essential.

  • Familiar with use of International Quality Management System standard

  • Quality Management System auditing certification, eg. ISO13485

  • Good knowledge of the Medical Device Directive and familiarity with its transposition

  • Good working knowledge of the Quality System Regulations as they pertain to customer complaints, post market activities & others.

  • Attention to detail and accuracy – essential

  • Skills that enable coordination of data, including MS-Office (primarily PowerPoint,Word, MD Project, Outlook and Excel);

  • Ability to take responsibility and ensure that all requested deliverables be provided according to agreed timelines.

  • Strong interpersonal and communication skills

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 .

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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