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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
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