**Regulatory Affairs Specialist** **Job Overview** Establish, maintain, and implement policies and practices related to creating and maintaining an active involvement in the legal and regulatory processes of covered Competent Authorities **You 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 team **To 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 Shift **How we work together** We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This role is an office role/Administrative Shift **About Philips** We 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. Learn more about our commitment to diversity and inclusion here. \#LI-PH1