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Head of Regulatory Affairs

Company: VirtualVocations
Location: Hartford
Posted on: November 7, 2024

Job Description:

A company is looking for a Head of Regulatory Affairs to lead regulatory strategy and operations for AI-driven medical technologies.



Key Responsibilities

Develop and implement regulatory strategies for compliance with FDA, MDR, and global requirements
Lead regulatory submissions and interactions with regulatory bodies
Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle


Required Qualifications

Bachelor's degree in a relevant field; advanced degree preferred
Minimum of 10 years of regulatory affairs experience in the medical device industry
Proven track record of successful regulatory submissions for AI-driven medical technologies
In-depth knowledge of AI and its regulatory implications
Certification in regulatory affairs (e.g., RAC) is highly desirable

Keywords: VirtualVocations, Springfield , Head of Regulatory Affairs, Other , Hartford, Massachusetts

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