IVDR Technical Manager
Company: VirtualVocations
Location: Vista
Posted on: May 24, 2025
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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, Encinitas , IVDR Technical Manager, Executive , Vista, California
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