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RAQA Specialist

  • Lead or staff
  • Hybrid
  • Full time
  • 8 to 10 years

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About the role

Intuitive develops robotic-assisted surgery systems and technologies for minimally invasive care. This specialist prepares medical device regulatory documentation, manages registrations, reviews marketing materials, and supports quality system activities.

What you'll do

  • Prepare and submit medical device technical documentation and registration dossiers
  • Assess regulatory impact of new devices and product changes
  • Coordinate registration strategies with sales and marketing teams
  • Review marketing materials for regulatory compliance
  • Respond to regulatory inquiries from internal stakeholders
  • Support CAPA, audits, and regulatory process improvement

Skills

Must have

  • Medical device regulations
  • Medical device registration
  • Regulatory documentation
  • Regulatory impact assessment
  • Regulatory review
  • Quality management systems
  • Capa
  • Audit

Nice to have

  • Us fda regulations
  • Iso 13485

Tools

  • Microsoft word
  • Excel
  • Powerpoint
  • Outlook

Who it's for

Education
Bachelor's degree
Degree
medical technology, life sciences, pharma
Experience
8 to 10 years
Languages
english
Domain
medical devices

About Intuitive (Intuitive Surgical India Pvt Ltd)

Intuitive (Intuitive Surgical India Pvt Ltd) has 26 open roles in Bangalore, at Intuitive Bengaluru (The Millenia). See every Intuitive (Intuitive Surgical India Pvt Ltd) role.

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