Dia Regulatory & Vigilance Specialist

Roche UK

Bosnia & Herzegovina
Eu ivdr directive compliance knowledge
Ivd medical device registration management
Fluency in local language and english
The role involves leading the registration and renewal of IVD medical devices while ensuring strict compliance with the EU IVDR Directive

Job Summary

  • The role involves leading the registration and renewal of IVD medical devices while ensuring strict compliance with the EU IVDR Directive.
  • Candidates will serve as the primary backup for Safety Board notifications and liaise with local distributors to submit critical safety documentation.
  • This is a temporary one-year contract position within the Roche DIA Adriatic Integrity & Impact Department based in Bosnia & Herzegovina.

Matching Summary

The role involves leading the registration and renewal of IVD medical devices while ensuring strict compliance with the EU IVDR Directive.

Skills & Requirements

Must-have

  • EU IVDR Directive compliance knowledge
  • IVD medical device registration management
  • Fluency in local language and English
  • Life Sciences degree required
  • Pharmaceutical or medical devices experience

Nice-to-have

  • Experience with competitive tender documentation
  • Ability to handle conflicting priorities
  • Strong organizational and planning skills
  • Matrix organization collaboration experience
  • Data-driven discussion leadership

Key Requirements

  • University Degree in Life Sciences
  • Work experience in pharmaceutical industry
  • Fluency in local language and English

Work Rights

Not specified

Tailored Resume

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