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 .