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INIntuitive

Regulatory Affairs Specialist(m/w/x)

Aubonne
Full-timeOn-siteExperienced
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Supporting EMEA product registrations and CE marking for robotic surgery devices. 3-5 years medical device regulatory affairs experience required. EUDAMED and Swissdamed system implementation.

Requirements

  • 3-5 years regulatory affairs experience in medical devices (EU regulations)
  • Bachelor's degree in Engineering, Medical Technology, or related field, or relevant experience
  • Solid knowledge of global medical device regulations (ISO 13485, EU MDR)
  • Experience with regulatory activities (sustaining, remediation, registration, labeling, CAPA, audit readiness)
  • Familiarity with EU compliance directives (RED, ROHS, Waste Framework Directive)
  • Strong organizational and planning abilities, proactive, results-driven
  • Excellent interpersonal skills for international/cross-department collaboration
  • High attention to detail for accuracy and completeness
  • Proficient English (minimum C1 level)
  • Skilled with Microsoft Office and Outlook
  • Able to work on-site in Aubonne, Switzerland
  • Familiarity with EUDAMED, Swissdamed, or similar structured regulatory systems
  • Experience with labeling or IFU remediation, language requirement assessments, or electronic IFU implementation
  • Experience supporting registration lifecycle maintenance, distributor documentation, or market documentation readiness
  • Experience with Smartsheet, Power BI, Jira, or similar tracking/dashboard tools
  • Exposure to clinical trial support activities in medical device environment

Tasks

  • Support registration activities across EMEA
  • Assist with CE marking for products
  • Handle non-medical product registrations
  • Support local registration processes
  • Implement EUDAMED and Swissdamed systems
  • Collect and verify data for EUDAMED and Swissdamed
  • Update trackers for EUDAMED and Swissdamed
  • Follow up with stakeholders on EUDAMED and Swissdamed
  • Support compliance activities
  • Manage CAPA processes
  • Follow up on audit findings
  • Prepare for inspections
  • Maintain RA documentation
  • Support RA operational tasks
  • Manage labeling and eIFU processes
  • Develop and maintain RA procedures
  • Update trackers and dashboards
  • Drive continuous improvement initiatives
  • Provide timely regulatory input to internal stakeholders
  • Coordinate follow-up actions for internal stakeholders
  • Support Quality Management System activities
  • Maintain controlled documentation
  • Support cross-functional teams within RA scope
  • Execute additional regulatory tasks and projects as assigned

Work Experience

  • 3 - 5 years

Education

  • Bachelor's degree

Languages

  • English – Business Fluent

Tools & Technologies

  • ISO 13485
  • Directive 93/42/EEC
  • Regulation 2017/745/EU
  • RED
  • ROHS
  • Waste Framework Directive
  • EUDAMED
  • Swissdamed
  • Smartsheet
  • Power BI
  • Jira
  • Microsoft Office
  • Outlook
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Intuitive and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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