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AMAmbu A/S

Innovation Process Owner(m/w/x)

Augsburg
Full-timeOn-siteExperienced

Evolving R&D processes and QMS for medical device development in clinical settings. Over 4 years medical device development experience with regulatory understanding and SOP writing essential. International team environment.

Requirements

  • Over 4 years medical device development experience
  • Understanding of medical device regulatory requirements
  • Experience writing SOPs or quality documentation
  • Fluency in English
  • Excellent communication, collaboration and presentation skills
  • Quality, efficiency and optimization mindset
  • Knowledge of ISO 13485

Tasks

  • Co-own product development and lifecycle management processes
  • Maintain processes within the Quality Management System
  • Evolve R&D processes for better efficiency and compliance
  • Conduct trainings on product development processes
  • Provide process consulting for the R&D organization
  • Prepare and support audits regarding development processes

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • ISO 13485

Benefits

Learning & Development

  • Personal development opportunities
  • Continuous professional development
  • Continuous personal development

Other Benefits

  • Professional employee benefits

Additional Allowances

  • Financial employee benefits
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