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Part Time/ Freelance Quality Assurance & Regulatory Affairs @ Healthark Wellness

Home > Quality Assurance - Other

 Part Time/ Freelance Quality Assurance & Regulatory Affairs

Job Description

Key Responsibilities:

  • Requirements gathering and regulatory analysis
  • Support with staffing strategy, screening, and interviews

Required Expertise:

  • Hands-on experience with ISO 13485 QMSCDSCO dossiers, and/or FDA/CE submissions
  • Familiarity with ISO 14971IEC 60601IEC 62304Indian MDR 2017EU 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

Job Classification

Industry: Medical Devices & Equipment
Functional Area / Department: Quality Assurance
Role Category: Quality Assurance - Other
Role: Quality Consultant
Employement Type: Part time

Contact Details:

Company: Healthark Wellness
Location(s): Hyderabad

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

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Healthark Wellness

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