Senior Regulatory Affairs Specialist
Company: VirtualVocations
Location: Santa Clara
Posted on: September 20, 2024
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Job Description:
A company is looking for a Senior Regulatory Affairs Specialist,
Medical Devices.
Key Responsibilities
Provide regulatory strategic leadership for medical device
products, including AI/ML-enabled devices
Lead regulatory submission teams and guide cross-functional teams
on regulatory decision-making
Conduct regulatory training programs on relevant topics and review
device labeling for compliance
Required Qualifications
Bachelor's degree in a technical or scientific field
8+ years of experience in Regulatory Affairs submissions for
medical devices and digital health products
Experience with FDA regulations and international standards for
medical devices
Technical proficiency in at least two relevant product
categories
Advanced degree or regulatory certifications preferred
Keywords: VirtualVocations, Santa Clara , Senior Regulatory Affairs Specialist, Other , Santa Clara, California
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here to apply!
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