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IVDR Technical Manager

Company: VirtualVocations
Location: Vista
Posted on: May 24, 2025

Job Description:

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

Keywords: VirtualVocations, Arcadia , IVDR Technical Manager, Executive , Vista, California

Click here to apply!

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