Philips Regulatory Affairs Specialist 

Costa Rica 

850598184

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

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