Role DescriptionYou will be responsible for the implementation of the QMS ISO 13485 and the submission of FDA requirements. You will have a responsible and independent role to support the company towards a succerful implementation of unique and life-saving Medical software. As QA/RA Manager you are responsible for the quality assurance and regulatory affairs strategy at a fast-growing medical device start-up. This concretely means further setting up a quality management system (ISO 13485), defining a regulatory strategy concerning MDR (Medical Device Regulation), succesfully submitting the FDA documentations that are required to operate in America and managing product registrations (such as CE marking). You will be responsible for the creation, documentation and maintenance of the (software) Technical Documentation for our medical devices.
Responsibilities- Assure the implementation of the ISO 13485 - Prepare and submid FDA documentation - Train colleagues how to be and stay compliant - Internal and external audits - Maintain the QMS, in order to stay compliant with the applicable European laws and standards. - Implement Change management and Risk Management
Requirements- At least 5 years of experience in QA and RA - Have experience with implementing a QMS from Zero - Experience with Medical Requirements ISO 13485 and preferably IEC 62304 - Strong communicator and able to show the company what way to take in terms of QA and RA - Entusiasm to make a difference in the Medical World and help prevent Skin Cancer all over the world.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.