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Senior Regulatory Affairs Specialist

Company: VirtualVocations
Location: Santa Clara
Posted on: September 20, 2024

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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