Product Regionalization Specialist (Medical Devices)

Quick Facts

• Role: Product Regionalization Specialist (Medical Devices)
• Focus: Labeling, manuals, and technical documentation for global device purchasing and manufacturing
• Key theme: Adapt deliverables to regional regulatory and market requirements
• Compliance: EU MDR/CE documentation requirements
• Collaboration: Product, development, test, and regulatory teams

Description

You will create and manage the documentation package that supports medical device purchasing and production. You will produce labeling materials and IFU (user and clinical manuals), adapt them to specific regions (including translations and region-specific technical updates), and consolidate outputs into final component documentation needed for the product (BOM). The role acts as a bridge between development, the product team, regulatory functions, and the end user.

Responsibilities

• Labeling & documents: Ensure correct labeling for each device and its components, manage related documentation, labels, and printing templates.
• Regional adaptation: Adjust labels, translations, and technical modifications so product and documentation meet local legislative requirements and market needs (e.g., power cable changes and region-specific software updates in the BOM).
• Manuals & technical documentation: Build and oversee user and clinical IFU, maintain clear structure and consistent terminology, and ensure required manufacturer information in line with EU regulations (MDR, CE).
• Information gathering & coordination: Work with product/project managers, development teams (Czech Republic, Bulgaria, India), and colleagues from testing and regulatory; proactively request inputs.
• Milestones: Track project timelines so deliverables are ready for notified bodies, certification authorities, and testing labs.
• System data management: Manage document cards, templates, and technical parameters in the internal information system Helios (or Codebeamer).

Requirements

• Technical university degree (major not specifically required)
• Logical thinking and ability to understand technical relationships
• Entry-level friendly: no long-term experience required; eagerness to learn and take ownership
• Strong attention to detail for a regulated medical device environment
• Proactive and communicative; able to organize work and drive tasks to completion
• Ability to adapt to changing assignments, legislative requirements, and new information
• Good English for daily written and spoken communication
• Advanced MS Word skills and Google Workspace proficiency
• Experience with or willingness to learn tools such as CorelDRAW, Codebeamer, and Helios

Benefits

• Work with real impact: your documentation directly influences how devices reach doctors and patients worldwide
• Varied work across regions, markets, and new devices (no routine)
• Comprehensive onboarding and ongoing support; start with existing projects alongside experienced colleagues, then transition to new independent work
• Friendly culture: informal environment, open communication, modern offices in Prague
• 5 weeks vacation, sick days, flexible working hours, meal allowance, annual bonus, learning courses, and other benefits