Regulatory Affairs Specialist - Newark New Jersey

Company: VirtualVocations
Location: Newark, New Jersey
Posted On: 02/03/2025

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 More...

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