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Philips Complaint Specialist (AEC-ECR) in Shenzhen, China

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In this role, you have the opportunity to

Describe in one impactful sentence the bigger purpose that this role contributes to in our company.

In this role, you have the opportunity to

  • As an AEC ( Adverse Event Coordinator) , you will support MDR (Medical Device Regulation)/adverse event reporting, triage complaint records, manage high-risk complaints to CA (Competent Authority). You are responsible for

  • Ensures timely medical device reporting by assessing complaints against reporting requirements and facilitating any required further investigation.

  • Write and submit medical device reports (MDRs) and / or regulatory reporting.

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

  • Provides consultation to investigator during initial check/ reportability determination

  • 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

  • Writes MDRs/MIR reports and submit to the necessary authorities

  • 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

  • The Emergency Care and Resuscitation Solutions (ECR ) Post Market Surveillance Team is headquartered out of Andover, MA. We welcome you to join Philips HealthTech as a Complaints Specialist supporting ECR. The Quality and Regulatory team enables meaningful innovation for our customers by partnering with and guiding the business to achieve world-class quality and regulatory compliance in a rapidly changing environment, while creating a great workplace for our people to realize their career aspirations. To succeed in this role, you should have the following skills and experience

  • Bachelor’s degree required. Technical degree in scientific or healthcare-related;

  • At least 3 years of Quality and/or Regulatory experience is required, experience in Post-market Surveillance is an advantage, Experience with Complaint Handling Software, Databases, and Microsoft Office is preferred, Previous experience in medical device and or applicable product is preferred;

  • Excellent Chinese and English communication skills are required (verbal, written, and presentation)

  • Medical device and or other regulated industry (Pharma, IVD) preferred

  • Basic knowledge of ISO13485

  • Local post market surveillance regulation (21CFR, MDD, EU-MDR and other applicable market regulation) and ISO14971;

  • Product knowledge is preferred.

  • Ability to effectively manage time.

  • Ability to handle multiple task assignments. In return, we offer you At Philips, we strive to make the world healthier and more sustainable through innovation, and our goal is to improve the lives of 3 billion people a year by 2025. This position offers the opportunity to influence regulatory compliance worldwide and directly improve the customer and patient experience. We offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. 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.

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