Senior Regulatory Affairs Specialist
Company: VirtualVocations
Location: Vista
Posted on: May 22, 2025
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Job Description:
A company is looking for a Senior Regulatory Affairs Specialist
- IVD.
Key Responsibilities
Lead product lifecycle management project teams and support
reporting assessments for product and facility changes
Oversee QMS/Compliance activities, including audits, Post Market
Surveillance, and CAPA
Collaborate with cross-functional teams to assess regulatory
impacts and ensure proper documentation for market protection
Required Qualifications
Bachelor's degree with 5+ years of related experience or Master's
degree with 3+ years of related experience
Understanding of Regulatory Affairs concepts and regulations for
IVD diagnostic products
Knowledge of US-IVD, CE-IVDD, and CE-IVDR governance
Familiarity with QMS and ISO standards, including ISO 13485
Keywords: VirtualVocations, Fountain Valley , Senior Regulatory Affairs Specialist, Other , Vista, California
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