Technical Writer, Regulatory Affairs

19 hours ago

hybrid Toronto ON Canada contract December Future Fertility Full time US$60,000 - US$120,000 per year
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.  

  • Technical Writer, Regulatory Affairs

    23 hours ago

    Toronto, Ontario, Canada Future Fertility Full time US$60,000 - US$90,000 per year

    HYBRIDTORONTO, ON, CANADA .CONTRACT . DECEMBER 5, 2025DescriptionContract Position - RAQA Technical WriterLocation: 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...

  • Senior Regulatory Writer

    1 week ago

    Canada Complete Regulatory | An IPG Health Company Full time

    Who we are: Complete Regulatory, part of IPG Health Medical Communications, is home to over 500 experts across some of the world’s most awarded med comms agencies. We blend science, creativity, and technology to deliver exceptional medical communications for pharmaceutical clients globally. What we do: We provide industry-leading regulatory writing and...

  • Senior Regulatory Writer

    2 weeks ago

    New Canada, NS Complete Regulatory | An IPG Health Company Full time

    Who we are: Complete Regulatory, part of IPG Health Medical Communications, is home to over 500 experts across some of the world's most awarded med comms agencies. We blend science, creativity, and technology to deliver exceptional medical communications for pharmaceutical clients globally. What we do: We provide industry-leading regulatory writing and...

  • Senior Regulatory Writer

    2 weeks ago

    toronto, Canada Complete Regulatory | An IPG Health Company Full time

    Who we are:Complete Regulatory, part of IPG Health Medical Communications, is home to over 500 experts across some of the world’s most awarded med comms agencies. We blend science, creativity, and technology to deliver exceptional medical communications for pharmaceutical clients globally.What we do:We provide industry-leading regulatory writing and...

  • Principal/Sr Medical Writer

    4 weeks ago

    Toronto, Canada Syneos Health Full time

    Principal/Sr Medical Writer (Regulatory & Publications) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...

  • Principal/Sr Medical Writer

    3 weeks ago

    Toronto, Canada Syneos Health Full time

    Principal/Sr Medical Writer (Regulatory & Publications) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...

  • Technical Writer

    4 weeks ago

    Toronto, Canada Hogarth Full time

    Hogarth is the Global Content Production Company. Part of WPP, Hogarth partners with one in every two of the world’s top 100 brands including Coca-Cola, Ford, Rolex, Nestlé, Mondelez and Dyson. Our global team of over 7,500 craft and technology experts brings together creative, production and innovation to help clients navigate this exciting and...

  • Senior Regulatory Writer

    4 weeks ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, Halton Hills, London, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Complete Regulatory | An IPG Health Company Full time

    Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Complete Regulatory | An IPG Health Company Senior Talent Acquisition Partner at IPG Health Medical Communications Who we are: Complete Regulatory, part of IPG Health Medical Communications, is home to over 500 experts across some of the world’s most awarded...

  • Technical Writer

    4 weeks ago

    Toronto, Canada Hogarth Full time

    Hogarth is the Global Content Production Company. Part of WPP, Hogarth partners with one in every two of the world’s top 100 brands including Coca-Cola, Ford, Rolex, Nestlé, Mondelez and Dyson.Our global team of over 7,500 craft and technology experts brings together creative, production and innovation to help clients navigate this exciting and...

  • Technical Writer

    22 hours ago

    Toronto, Ontario, Canada Eram Talent Full time $48,000 - $120,000 per year

    Eram Talent, a renowned talent acquisition company, is seeking an experienced Technical Writer focused on the Oil & Gas sector to join our team in Saudi Arabia. This role is essential for producing high-quality documentation that captures technical specifications, project methodologies, and regulatory compliance within the oil and gas industry. As a...