Product Design Control SpecialistVirtualVocations • Louisville, Kentucky, United States
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Product Design Control Specialist
VirtualVocations • Louisville, Kentucky, United States
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A company is looking for a Product Design Control Specialist.
Key Responsibilities
Liaise between Product and Regulatory teams for all product DHF deliverables
Drive timelines for product deliverables, ensuring timely release and / or submission
Create and maintain project-specific technical file deliverable lists aligned with internal SOPs
Required Qualifications
5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience
3+ years in a regulatory project management or technical role
Experience working in a regulated agile development environment
Familiarity with global medical device regulations : QSR / QMSR, MDD / CMDR / MDR
Experience with eQMS and ALM systems, including enacting QMS requirements
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Design Specialist • Louisville, Kentucky, United States
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