Authoring, editing, and providing guidance on the development and implementation of new and updated documents, including but not limited to, the following: validation protocols and reports, product & material specifications, design & development documentation, SOPs, quality investigations, plans, and QMS support documents. Maintains a thorough understanding of the currently recognized state-of-the-art, including, but not limited to, the following: 21CFR820, ISO 13485, Regulation 2017/745 (EUMDR), the Canadian Medical Device Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory requirements.