IVDR Technical Manager

Job Summary

A company is looking for an IVDR Technical Manager to ensure compliance with regulatory and accreditation requirements for in-vitro diagnostic devices.

Key Responsibilities

• Manage the competence process for technical roles, ensuring compliance with accreditation and regulatory requirements
• Collaborate with sales and planning teams to enhance operational cooperation and promote best practices
• Stay updated on IVDR and EU regulatory requirements, providing training and support to internal teams

Required Qualifications

• Bachelor's or Master's degree in Life Sciences, Engineering, Medical Technology, or a related field
• At least 5 years of experience in regulatory affairs, technical documentation, or quality management in the medical device or IVD industry
• At least 2 years of direct experience with IVDR or IVDD
• Experience in preparing technical files, design dossiers, and risk management documentation for IVD products
• Strong understanding of IVDR and EU regulatory requirements for IVD products