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 in vitro diagnostic medical device certification and conformity assessment processes
• Develop and maintain QMS documentation aligned with regulatory and accreditation requirements

Required Qualifications

• Four years of professional experience in the TIC industry, with two years in relevant healthcare product design or manufacturing
• Management experience of global teams
• Strong project management and stakeholder management skills
• Successful completion of a university or technical college degree in relevant sciences
• Extensive knowledge of medical device compliance and auditing techniques