Freelance Regulatory Affairs Expert (m/w/d)

  • Referenznummer: 6548
  • Branche: Medizintechnik
  • Einsatzort: Zürich
  • Beschäftigungsform: Freiberuflich
  • Beginn des Projekts: ASAP
  • Dauer: 6 Monate
Ihre Aufgaben:
  • Support of product development in cross functional teams
  • Creation, review and/or approval of documents of the design control process
  • Accountable for regulatory compliance
  • Support international product registration
  • Assessment, approval and regulatory implementation of change requests
  • Review and approval of product related labeling and marketing material
  • Support SAP based reporting systems
  • Training internally on relevant procedures and requirements
Ihre Qualifikationen:
  • Understanding of regulatory requirements, applicability and implementation in practice
  • Understanding for product development process and principles of design control
  • Development, review and release of all documents required for technical files
  • Interpersonal skills and multitasking
  • Good Knowledge of medical device legislation EU ,US and CAN and corresponding guidelines
  • Good knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
  • Fluent in English, further languages are an advantage
  • Excellent writing and communication skills
  • Experience in preparation for notified body audits and FDA inspections are an advantage