JOB DESCRIPTION Job TitleRegulatory Affairs SpecialistJob DescriptionRegulatory Affairs SpecialistPhilips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation.
Driven by the vision of a better tomorrow.But it's not just what we do, it's who we are.
We are 80,000, wonderfully unique individuals, with two things in common.
and a relentless determination to deliver on our customers' needs.
It's what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more.
That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.Job OverviewEstablish, maintain and implement policies and practices related to creating and maintaining an active involvement in the legal and regulatory processes of covered Competent AuthoritiesYou are responsible for:Seek out and evaluate changes to standards and regulations affecting Philips Image Guided Therapy Corporation products.
Define and maintain the process needed to keep the relevant team and supervisors informed about potential impact products and their respective QMSs throughout the products lifecycle.Responsible for project management specific to ensuring that applicable medical device standard or guidance are understood and properly implemented within the Philips Image Guided Therapy Corporation QMS.
Maintains project data necessary to understand assumptions made, progress made, and issues or risks associated with the projects.
Organizes the archives of project information.
Teaches project stakeholders how to effectively access information to help drive appropriate decisions.As required, prepares and submit product specific applications seeking marketing authorization to applicable International Regulatory bodies to maintain market access.
Responsible for reviewing and approving change requests for already commercialized products to ensure Market and Regulatory Compliance.Trains Costa Rica site personnel on the responsibilities and functions of the Regulatory Affairs department and interacts with the different areas to foster a unified way of working.Supports Audits by providing active support and collaboration to the front and backroom audit teamTo succeed in this role, you'll need a customer-first attitude and the following:Bachelor's degree in a technical discipline such as Science, Industrial Engineering, or Law or a combination of equivalent job experience in related field.Minimum of 3-5 years of experience in the medical device or pharmaceutical industry and technical environment.Must have experience with preparation and submission of international documents or registration and marketing of medical device worldwide.Excellent working knowledge of medical device regulations (21CFR, ISO 13485), FDA Law, MDR, other global laws and regulations.Experience in supporting international registrations.Advanced English.
Administrative ShiftAbout PhilipsWe are a health technology company.
We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.
Do the work of your life to help the lives of others.• Learn more about our business.• Discover our rich and exciting history.• Learn more about our purpose.If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.
You may still be the right candidate for this or other opportunities at Philips.
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