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Part Time/ Freelance Quality Assurance & Regulatory Affairs

Part Time/ Freelance Quality Assurance & Regulatory Affairs

Healthark Wellness Solutions

5 - 8 years

9 - 11 Lacs

Hyderabad

Posted:2 days ago| Platform:

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Skills Required

EU MDR ISO 13485 QMS FDA/CE submissions Regulatory Affairs CDSCO dossiers

Work Mode

Remote

Job Type

Full Time

Job Description

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

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Healthark Wellness Solutions

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