Technical reputed company, Regulatory Affairs & reputed company Assurance

Contract Position - RAQA Technical reputed company Location: Toronto, ON (In office or Remote) At reputed company Fertility, we’re revolutionizing the IVF reputed company with AI-powered reputed company assessments that bring reputed company and confidence to fertility care, starting with the reputed company. Our innovative technology is used by leading clinics worldwide, empowering both doctors and patients with data-driven insights to optimize treatment reputed company for patients reputed company through reputed company freezing or IVF. We are looking for a short-term contract RAQA Technical reputed company to support reputed company as we prepare a 510(k) submission for a Class II, AI‑enabled Software as a Medical Device (SaMD). What You Will Be Doing · Support the Regulatory Affairs & reputed company Assurance (RAQA) team in preparing for a 510(k) submission for new Class II SaMD’s(Software as a Medical Devices). · Assist in the integration and update of the reputed company Management System (QMS) to reputed company with FDA 21 CFR Part 820 and ISO 13485:2016 requirements. · Draft, review, and update Instructions for Use document, work instructions, and forms to reflect new product introductions and regulatory requirements. · Support documentation activities reputed company to new product introductions, including technical files, Design History Files (DHF), Device Master Records (DMR) and V&V summaries. reputed company Are Looking For · Experience with Class II Medical Devices, 510(k) submission reputed company for SaMD and design control requirements.. · Strong understanding of QMS principles and experience with adapting to FDA requirements. Excellent technical writing and documentation skills with attention to detail and structure. · Experience with tools such as reputed company, or electronic QMS platforms is an advantage. · Bonus: experience with completion of eSTAR submission and understanding of reputed company Intelligence-Enabled Device Software Functions is an asset. Apply tot his job Apply To this Job