Post Market Surveillance Specialist

Job Description

Job Title

Job Description

Philips is focused on improving people's lives through meaningful innovation. Our aim is to improve the lives of 2.5 billion people a year by 2030. We have a global footprint, with an established presence in both mature and growth geographies. Oral healthcare is an important part of our strategy to enhance consumer health and well-being and an important growth driver of our portfolio.

Your opportunity

We have an opportunity for Quality Post Market Surveillance Specialist to join our team based in North Ryde, Sydney on a 2 year contract

Reporting to the Head of Quality ANZ, this position is key in improving & maintaining business regulatory compliance and as well as enhancing customer satisfaction. You will be executing the implementation & maintenance of on-going post market surveillance activities within Philips and ensuring that legislative requirements both in the region and globally are met whilst providing regular status reports to Management and Regulatory Authorities as required.

Your key main responsibility will be:

• To enhance customer satisfaction, improve business information and maintain compliance by championing key areas within the post market surveillance such as Adverse Event, complaints and product correction reporting.
• Support in handling customer feedback & adverse event reporting
• Assists in product safety issues investigations and proposes measures to prevent unintended use and adequate communication with local authority.
• Timely execution of Incident reporting to regulators as per defined timelines as per local regulatory requirements.

We are looking for

• You will have an Engineering/Science qualification and a minimum of 3 years experience within complaints/ post market surveillance within a Medical device or engineering environment.
• Previously had regular experience with Competent Authority medical device regulations especially with the TGA/ Medsafe.
• Familiar with use of International Quality Management System standard and ISO9001, ISO 13485, FDA QSR, local ANZ laws.
• Good working knowledge of the Quality System Regulations as they pertain to customer complaints, post market activities & others.
• It goes without saying you will be strong in your attention to detail and accuracy as well as intermediate knowledge of the MS Suite.

Why should you join Philips?

We offer a dynamic, fast paced and inclusive environment that will enable you to further develop your talents and career within a global leader. We offer a competitive salary and incentive package.

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 by 2030 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.

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.

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