IVDR Team Leader

Job Summary

A company is looking for a Global Team Leader - IVDR.

Key Responsibilities

• Lead the team of IVDR product assessors and manage the in vitro diagnostic medical device training process
• Provide technical expertise and support for the in vitro diagnostic medical device conformity assessment process
• Develop and maintain QMS documentation aligned with regulatory requirements and best practices

Required Qualifications

• Four years of professional experience in the TIC industry, with two years in design, manufacture, testing, or use of medical devices
• Management experience of global teams
• Successful completion of a university or technical college degree in relevant studies (e.g., Microbiology, medicine, pharmacy, engineering)
• Extensive knowledge of medical device management systems and compliance regulations
• Strong project management and stakeholder management skills