Job Description

JOB DESCRIPTION

Job Title

Principal Regulatory Affairs Specialist

Job Description

As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal Regulatory Affairs Specialist will lead and provide regulatory oversight for critical new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA, and other governmental agency/notified body Regulatory Compliance standards/requirements.

Your Role:

  • Leads business critical new product development projects and provide regulatory oversight to maintain lifecycle ensuring that requirements are maintained. Identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to projects teams and RA management. Mentor and coach Philips Ultrasound regulatory professionals in their development.
  • Will negotiate directly with regulatory enforcement entities (e.g. governmental agenc...

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