Regulatory Affairs Specialist

April 25

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SprintRay Inc.

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Crafting the Next 100 Years of Dentistry

3D Printing • 3D Modeling • Research and Development • Technology • Manufacturing of 3D Printers

501 - 1000

💰 $100M Series D on 2022-10

Description

• Provide RA-QA support to ensure compliance with ISO 13485 MDSAP, and FDA QSR for all products • Implement and maintain the Company's Quality Management System • Follow regulatory guidance to ensure standards and requirements are consistently met • Stay up to date with the new regulations for the medical device manufacturing companies • Helping the RA-QA team in regulatory submissions

Requirements

• 3+ years of experience in regulatory compliance and QA • Previous experience in Medical Devices • Previous experience working in a RA-QA-related function • Previous experience with implementation of a Quality Management System • Strong knowledge and understanding of ISO 13485, MDSAP, and FDA QSR compliance • Understanding Quality Management System • Knowledge and understanding of regulatory affairs • BS in Chemical or Biomedical Engineering or a related field • Extremely organized and detailed oriented • Have great time management skills • Have excellent written and verbal communication skills in English • Be a team player, as well as being able to work independently

Benefits

• Annual performance bonus • Medical/dental/vision benefits • Other applicable compensation