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olutions across the <a href="" target="_blank">health continuum </a>. Our people experie
lso learn about our <a href="" target="_blank">recruitment process </a>, or find answers to
some of the <a href="" target="_blank">frequently asked questions </a>. </p><p></p></body></html>
ways. Learn more by <a href="" target="_blank">watching this video </a>. </p><p></p><p>To find out mor
ad stories from our <a href="" target="_blank">employee blog </a>. Once there,you can
al level, visit the <a href="" target="_blank">Working at Philips page </a> on our career websi

Job Information

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


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 .