Siemens Healthineers Canada is seeking a Senior Regulatory Affairs Specialist to lead submissions for FDA 510(k), IVDR, and other regulatory activities. This remote role supports cross‑functional teams and quality systems, ensuring compliant lifecycle documentation.
The ideal candidate has 4+ years in IVDs or medical devices, GMP experience, and solid communication skills. You will train stakeholders, review labeling, and prepare technical files while staying audit‑ready in a dynamic healthtech