Regulatory Affairs -Quality Professional

Job Description

RAQA (Regulatory Affairs Quality Assurance) professional is responsible for implementation of process across the assigned projects,
• Process facilitation to project teams from Initiation till Release of the project
• Conduct audit to identify process gaps in the project
• Review the project deliverables and provide feedback to project teams
• Improve process awareness amongst employees by conducting training programs
• Define relevant project metrics and Perform statistical analysis on metrics data collated
• Conduct Lessons Learned session
• Regulatory related documents to be maintained in the centralized tool
What do I need to qualify for this job?
• Education: BE / B.Tech / MCA / ME / M.Tech/ Graduate from a recognized university
• 3-7 yrs of experience in Software Quality Assurance / Medical Devices / Regulatory
Desired Skill Set:
• Experience in implementation of Design Controls across projects
• Knowledge on various software development life cycle methodologies
• Good knowledge of ISO 13485, 14971, 21 CFR Part 820, IEC 62304
• Proficient in using Microsoft office
• Strong presentation skills and ability to interact with Business Partners
• Excellent interpersonal skills and ability to work independently
• Strong written and oral communication skills

Organization: Siemens Healthineers

Company: Siemens Healthineers India LLP

Experience Level: Experienced Professional

Job Type: Full-time

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