Location: Bothell, WA
Job Summary:
Job Duties and Scope
- Develop and communicate regulatory strategies and project risk assessments.
- Lead new product development projects and mentor regulatory professionals.
- Negotiate with regulatory entities and provide guidance on global compliance.
- Represent Philips in audits and provide support for clinical studies.
Required Skills
- Strong understanding of global regulatory requirements.
- Proven experience with Software as a Medical Device (SaMD) and Ultrasound Imaging Devices.
- Excellent communication skills and adaptability.
Required Experience
- Minimum of 7 years in Regulatory Affairs for FDA regulated Medical Devices.
- Expertise with regulatory submissions including 510K’s, PMA, and EU MDR.
- Bachelor’s degree in Regulatory Affairs, technical/Engineering, or business discipline; RAC preferred.
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