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Regulatory Lead
Dognosis
Legal
Bangalore Urban, Karnataka, India
Posted on Feb 3, 2026
At Dognosis, we're redefining early disease detection by combining the olfactory brilliance of trained canines with neuroscience and AI. We're building the world's most advanced canine-assisted early cancer detection system and need a Regulatory Affairs & Quality Lead to establish our compliance infrastructure and drive accreditation as we scale from lab to clinic.
What You'll Do
- Design, implement, and maintain our Quality Management System (QMS) from the ground up
- Lead ISO 17025 and ISO 15189 accreditation strategy and serve as primary liaison with regulatory bodies (CDSCO, NABL, CLIA, etc.)
- Establish and maintain compliance frameworks for HIPAA, ISO 27001, DPDP, and data protection/privacy requirements
- Navigate LDT regulatory pathways and prepare technical files for diagnostic submissions
- Drive internal and external audits, establish CAPA protocols, and ensure audit readiness
- Develop SOPs and technical documentation for diagnostic workflows, data handling, and research operations
- Build cross-functional compliance culture across scientific, clinical, and operational teams
What You Bring
- Bachelor's in life sciences, biotechnology, or related field (master's preferred)
- 5+ years in regulatory affairs and quality assurance (biotech, medtech, diagnostics, or clinical labs)
- Proven experience with ISO 17025, ISO 15189, CLIA, and LDT frameworks
- Working knowledge of HIPAA, ISO 27001, DPDP, and healthcare data protection regulations
- Track record of building QMS frameworks and navigating regulatory submissions
- Strong leadership, documentation, and cross-functional collaboration skills
- Self-directed, detail-oriented, and comfortable building systems in a fast-paced startup environment
Join us in building regulatory excellence that saves lives.