Regulatory Affairs

22 hours ago

Bengaluru, India Siemens Healthineers Full time

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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