Device Compliance and Regulatory Expert

4 days ago


Reading, Reading, United Kingdom Occuity Full time
About the Role

We are seeking a talented Medical Device Quality Specialist to join our Quality Management System (QMS) team in Reading. As a key member of our team, you will be responsible for ensuring the quality and safety of our medical devices, from design to launch.

Responsibilities

Your primary duties will include:

  • Risk Management: Develop and review documentation required for risk management, ensuring compliance with regulatory requirements such as ISO 13485, EU MDR 2017/745 & 21CFR820.
  • Design and Development: Support the generation and review of design history files, including verification and validation activities for R&D prototypes.
  • Quality Activities: Facilitate effective risk management activities, both internally and externally with manufacturing facilities.

As a Medical Device Quality Specialist, you will work closely with cross-functional teams to ensure the quality and safety of our products. You will be responsible for reviewing and approving project-related documentation, generating regulatory submission data, and providing input into verification and validation activities.

This is a fantastic opportunity for a motivated individual who is passionate about improving people's health around the world. If you have a keen eye for detail, excellent communication skills, and experience in coding software (e.g. MATLAB, C++, Arduino), we encourage you to apply.



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