Regulatory Affairs Specialist Jobs

• Provide audit, CAPA and post market regulatory support
• Maintain regulatory files and tracking databases as required
• Communicate application progress to internal stakeholders
• Mentor other regulatory affairs personnel within HPM Regulatory
• Communicate with regulatory agencies as needed
• Ensure standard and process compliance.
• Collaborate with worldwide colleagues regarding license renewals and updates
• Lead a team within Regulatory or Cross Functional Team to set and deliver the objectives

• Strong background in Design Controls.
• Able to work effectively with minimal supervision
• Proficient computer skills in Microsoft Office Suite
• May require 5% travel annually with possibly some international.
• Proficient knowledge of domestic and international standards
• Experience in supporting international registrations and/or clinical investigations.
• ASQ certifications also desirable.
• Experience with Software Medical Devices strongly preferred.
• Minimum of 5 years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II or class III, etc.).
• Understand LEAN concepts, methodologies and deployment.
• Master’s preferred preferably in Regulatory Affairs and/or related field (or equivalent experience in the medical device industry)
• RAPs RAC strongly preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
• Bachelor’s degree required in a technical discipline.
• Proficient knowledge of medical device regulations minimum FDA and Canada, Worldwide is desired. Must have personal experience with successful preparation and submission of 510(k) submissions.

About Philips

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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.

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