Location: Bothell, WA
Job Summary:
Job Duties
- Develop regulatory strategies and communicate project risks.
- Lead new product development and mentor regulatory professionals.
- Communicate/negotiation with regulatory entities on filings.
- Represent Philips in audits and provide support for clinical studies.
- Partner with global regulatory affairs and cross-functional teams.
Required Skills (Keywords)
- Regulatory strategies
- Risk management
- Regulatory compliance
- Communication
- Regulatory submissions
- Quality Management System
Required Experiences (Topics)
- 7+ years in Regulatory Affairs for FDA regulated Medical Devices.
- Experience with Software as Medical Device (SaMD).
- Knowledge of global regulatory requirements.
- Bachelor’s degree in relevant fields; RAC preferred.
Job URLs: