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Post Market Surveillance Consultant I

Ampcus, Inc
United States, Virginia, Chantilly
14900 Conference Center Drive (Show on map)
Sep 22, 2024

Correction and Removal Specialist

In this role, you have the opportunity to The Correction and Removal (C&R) Specialist will support the execution of the correction and removal process. You will work with international teams in a collaborative environment to complete the end-to-end correction and removal process.

You are responsible forManage C&R responses and C&R file documentation. Review return device authorizations for accuracy and close as appropriate. Create return device authorizations as needed. Provide ongoing information to C&R and FCO team as required. Additional projects as assigned. You are a part of The Respironics Team is headquartered out of Pittsburgh, PA. We welcome you to join Philips HealthCare. 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 1-2 years of post-market surveillance experience in a medically regulated industry.

Bachelor's degree in engineering, clinical sciences, related sciences, or relevant related experience. Proficiency in using office tools such as Microsoft Office Suite and various other computer software applications.Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR. Medical Device and or other regulated industry (Pharma, IVD,). An organized, analytical thinker with exceptional attention to detail.An excellent and responsive communicator, both written and verbal for coordinating with colleagues and management.Ability to perform tasks in a highly complex environment.Able to exercise sound judgment within Philips using standard operating procedures and policies to determine the appropriate action to achieve objectives. 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.

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