About this role
Role Overview
- Lead and provide regulatory oversight for new product development projects
- Negotiate directly with regulatory enforcement entities on regulatory filings
- Mentor and coach Philips Ultrasound regulatory professionals
- Drive improvement in regulatory aspects of the Quality Management System
- Provide regulatory support for clinical studies and recommend optimization strategies
- Provide guidance on regulatory compliance procedures globally
Requirements
- 8+ years’ Regulatory Affairs experience within FDA regulated Medical Device/HealthTech product environments
- Experience with Software as Medical Device (SaMD) and Ultrasound Imaging Devices highly desired
- Strong knowledge of US FDA, China NMPA, CE Marking, EU MDD/MDR, JPAL, Canadian CMDCAS
- Proven/successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally
- Minimum of a Bachelor’s Degree in Regulatory Affairs, Engineering, Life Sciences or comparable disciplines
- Master’s degree, RAC Certification desired
Benefits
- PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement