Regulatory Affairs Specialist I
Philips
San Diego
Workplace: OnsiteFull timeUSD 63,000 - 112,000 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 1+ yearsEducation: bachelorsSkills: ["Stakeholder relationship building","Regulatory analysis","Cross-functional collaboration","Attention to compliance","Continuous improvement"]Support regulatory activities for Philips Image Guided Therapy Devices to ensure safety, effectiveness, and compliance across global markets. Help prepare and maintain regulatory documentation, assist with submissions and renewals, and contribute to Technical Documentation and Design History Files. Research and interpret FDA, EU MDR, and other international requirements, partner with cross-functional teams, and support post-market surveillance, audits, inspections, and continuous improvement.
