Sr RA Specialist, APAC Indirect Mkts

Added
1 hour ago
Type
Full time
Salary
Salary not provided

Related skills

agile smartsheet regulatory veeva trackwise

๐Ÿ“‹ Description

  • Execute the regulatory strategy for obtaining registration approval of Intuitive's portfolio
  • With limited supervision, coordinate with Distributor RA to compile regulatory documentation for
  • Evaluate medical device changes, determine and execute regulatory strategy and ensure compliance.
  • Work closely with respective Intuitive BU RAs to execute regulatory plans for medical device
  • Communicate with Distributor RAs and Intuitive's stakeholders (BU RAs, Commercial, PLO, PMO
  • Together with the Distributor RAs, determine the types of regulatory submissions or internal

๐ŸŽฏ Requirements

  • At least a bachelor's degree in Medical Technology, Life Sciences, Pharma or similar sciences.
  • Knowledge of ISO13485, GDPMDS or similar quality management system requirements and broad
  • Experience with Agile, Veeva, TrackWise or similar regulatory information management systems.
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