DSJ Global is currently partnered with a global leader of high quality fiber optical solutions that is looking to add a Quality and Regulatory Manager to their team in Williamsburg, Virginia.
Responsibilities:
* Maintain and develop quality management system
* Gain understanding of new regulations, perform gap assessment, and assist with updates to the quality manual, operating procedures, and other documentation to ensure compliance
* Lead external audits by the Notified Body, by the FDA, or other regulatory authorities, and customers
* Assist with maintenance and creation of technical documentation for medical devices
* Prepare and submit FDA product applications and manage product recalls of medical devices
Qualifications:
* Bachelor's degree in scientific or engineering related field
* 3-5 years of experience working in quality systems pertaining to ISO 13485, FDA 21 CFR820, EU MDD/MDR
* Preferred experience in the medical device industry