Regulatory Affairs Specialist
Company: VirtualVocations
Location: Newark
Posted on: February 1, 2025
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Job Description:
A company is looking for a Regulatory Affairs Specialist
(REMOTE).
Key Responsibilities
Ensure compliance with local regulations for software within North
America
Develop and implement regulatory strategies for product approvals
and maintain relationships with regulatory authorities
Provide regulatory support throughout the software development
lifecycle and review marketing materials for compliance
Required Qualifications, Training, and Education
Bachelor's Degree required
3+ years of experience in the medical device industry
3+ years of experience in a regulated environment (CFR21 Part 820,
ISO13485, ISO14971)
1 year of experience with regulated software under IEC 62304 and
Agile Development Process
Familiarity with FDA 510(k)s, EU MDR, and Health Canada Medical
Device Applications preferred
Keywords: VirtualVocations, East Orange , Regulatory Affairs Specialist, Other , Newark, New Jersey
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