Demo

Regulatory Compliance Manager

Jobleads-US
Center, PA Full Time
POSTED ON 4/7/2025
AVAILABLE BEFORE 5/5/2025

Role Overview:

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The Senior Director, Design Assurance will lead the Global Design Assurance team to ensure Olympus products meet the highest quality and regulatory standards. This role will develop and implement compliant design control processes, manage governance mechanisms, and drive product quality and compliance objectives.

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The ideal candidate will have a strong background in quality management, design assurance, and regulatory compliance, with excellent written and oral communication skills. They will possess the ability to operate independently and highly autonomously, holding themselves accountable to proactively fulfill tasks and achieve results within assigned timelines.

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Responsibilities:

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  • Developing and implementing compliant design control processes
  • Managing governance mechanisms to drive product quality and compliance objectives
  • Ensuring Olympus products meet the highest quality and regulatory standards
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Requirements:

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  • Bachelor's degree or equivalent in a Life Science focus, Engineering, or Physical Science required
  • Minimum of 15 to 20 years of experience in quality management or design assurance
  • Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry
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About Olympus:

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Olympus is a global medical technology company committed to making people's lives healthier, safer and more fulfilling. We partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

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