Senior Regulatory Affairs Specialist

Responsibilities

• Develop and execute regulatory strategies for new product development, design changes, and field safety corrections for US, EU, and Rest of World markets
• Lead 510(k) submissions, EU MDR Technical Documentation preparation, and Health Canada license applications
• Collaborate with cross-functional teams including R&D, design quality, marketing, and supply chain to create submission contents
• Monitor global regulatory landscapes and support the implementation of regulation changes to minimize business impact
• Provide regulatory assessments of product changes for both launch and sustaining activities
• Support activities required to maintain regulatory compliance as new or revised versions of standards and guidance documents are published

Requirements

• Bachelor's or Master's degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law, or equivalent
• 10+ years of experience with a Bachelor's degree or 2+ years of experience with a Master's degree in Regulatory Affairs, Quality Compliance, or Medical Device Product Development
• Deep knowledge of regulatory requirements including 21 CFR 820, EU MDR, and ISO 13485
• Proven experience with 510(k) submissions, Health Canada licenses, and EU MDR Technical Documentation
• Experience with product registrations and labeling for US, EU, and Canada markets

Preferred Qualifications

• Experience with Quality Management Systems (QMS)
• Skills in troubleshooting, KPI monitoring, and reporting
• Strong data analysis and interpretation capabilities
• Experience with process improvements within a regulatory framework

About the Company

Philips is a global health technology company dedicated to improving people's health and wellbeing through meaningful innovation. We focus on advanced technology and deep clinical insights across Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/Connected Care, Sleep & Respiratory Care, and Personal Health.