Regulatory Affairs

15 hours ago

Karnataka India Dognosis Full time ₹ 6,00,000 - ₹ 18,00,000 per year

At Dognosis, we're redefining early disease detection by combining the olfactory brilliance of trained canines with neuroscience and AI. As we work toward building the world's most advanced canine -assisted early cancer detection system, we are seeking a Regulatory Affairs & Quality Associate to support our ISO 17025 accreditation and ongoing compliance processes. This role is critical in ensuring our diagnostic workflows and research operations meet the highest regulatory and quality standards as we scale our systems from lab to clinic. You will be responsible for maintaining and updating documentation for our Quality Management System (QMS), supporting internal audits, managing corrective and preventive actions (CAPA), and helping prepare technical files and regulatory submissions. Working closely with scientific and operational teams, you'll ensure documentation accuracy, SOP compliance, and audit readiness. This is a unique opportunity to contribute to a cross -disciplinary team where precision and regulatory excellence have a direct impact on saving lives. RequirementsThe ideal candidate holds a bachelor's degree in life sciences, biotechnology, or a related field and brings 2–3 years of hands -on experience in regulatory or quality assurance roles within biotech, medtech, diagnostics, or laboratory environments. A working knowledge of ISO standards, particularly ISO 17025, 15189, or 13485, is essential, along with strong document control skills, attention to detail, and a structured approach to quality compliance.Additional advantages include direct experience with ISO 17025 accreditation processes, familiarity with regulatory bodies such as CDSCO, NABL, or similar, and a comfort level with preparing for audits or inspections. The role demands a self -motivated and methodical professional who values high -quality, reproducible science and is eager to grow in a fast -paced, impact -driven environment.

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