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IVDR Technical Manager
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
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
