Healthark Wellness Solutions

Key Responsibilities: Requirements gathering and regulatory analysis Support with staffing strategy, screening, and interviews Required Expertise: Hands-on experience with ISO 13485 QMS , CDSCO dossiers , and/or FDA/CE submissions Familiarity with ISO 14971 , IEC 60601 , IEC 62304 , Indian MDR 2017 , EU MDR , and FDA 510(k) processes Strong grasp of technical documents: specs, schematics, test protocols, engineering terminology Excellent documentation, analytical, and communication skills Ability to work independently in a fast-paced, startup-like environment