Technical Writer, Regulatory Affairs

1 week ago

Toronto, Canada Future Fertility Inc Full time

/ Technical Writer, Regulatory Affairs & Quality Assurance# Technical Writer, Regulatory Affairs & Quality Assurancehybrid Toronto, ON, Canada . contract. December 5, 2025Description**Contract Position - RAQA Technical Writer********Location:** Toronto, ON (In office or Remote)At **Future Fertility**, we’re revolutionizing the IVF journey with AI-powered quality assessments that bring clarity and confidence to fertility care, starting with the egg. Our innovative technology is used by leading clinics worldwide, empowering both doctors and patients with data-driven insights to optimize treatment decisions for patients going through egg freezing or IVF.We are looking for a short-term contract RAQA Technical Writer to support our team 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 & Quality 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 Quality Management System (QMS) to align 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 related to new product introductions, including technical files, Design History Files (DHF), Device Master Records (DMR) and V&V summaries.**What We Are Looking For**· Experience with Class II Medical Devices, 510(k) submission pathway 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 Confluence, or electronic QMS platforms is an advantage.· Bonus: experience with completion of eSTAR submission and understanding of Artificial Intelligence-Enabled Device Software Functions is an asset.
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