Dia Regulatory & Vigilance Specialist

Roche

Sarajevo, Bosnia & Herzegovina
**
Ivd medical device registration
Eu ivdr directive compliance
Rims medtech platform
** Roche is seeking a Dia Regulatory & Vigilance Specialist for a temporary one-year contract in Sarajevo, Bosnia & Herzegovina. The role involves regulatory compliance for IVD medical devices, including registration, documentation, and collaboration with local distributors and regulatory authorities. **

Job Summary

  • Lead the registration and renewal of IVD medical devices in the RA Register, ensuring all technical documentation is accurate and compliant.
  • Prepare and manage notifications of change in strict accordance with the EU IVDR Directive (2017/746) and monitor ongoing implementation requirements.
  • Engage in local and global meetings and training to align local regulatory activities with international standards.

Matching Summary

Match Score: 75

** Roche is seeking a Dia Regulatory & Vigilance Specialist for a temporary one-year contract in Sarajevo, Bosnia & Herzegovina. The role involves regulatory compliance for IVD medical devices, including registration, documentation, and collaboration with local distributors and regulatory authorities. **

Skills & Requirements

Must-have

  • IVD medical device registration
  • EU IVDR Directive compliance
  • RIMS MedTech platform
  • Safety Board notifications
  • liaise with local distributors
  • clinical trials oversight

Nice-to-have

  • personal expression and open dialogue
  • genuine connections and respect
  • thrive personally and professionally
  • advance science and access to healthcare

Key Requirements

  • University Degree in Life Sciences
  • Work experience in pharmaceutical industry
  • Fluency in local and English languages
  • Knowledge of medical devices regulatory processes

Work Rights

Not specified

Tailored Resume

Cover Letter