Sr. Regulatory Affairs Specialist
Position: Sr. Regulatory Affairs Specialist
Location: Kennesaw, GA (Hybrid)
Experience Required: 8+ years
Our client is seeking an experienced Sr. Regulatory Affairs Specialist to support Class III medical device product life-cycle activities at their site near Atlanta, Georgia. This role ensures timely execution of regulatory deliverables, compliance with global regulations, and effective cross-functional collaboration with internal teams.
Key Responsibilities-
Prepare and submit US FDA PMA submissions and related documentation.
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Support and maintain Canadian medical device licenses .
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Conduct regulatory impact assessments for product and process changes.
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Develop, maintain, and track PMA-related documentation and regulatory deliverables.
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Provide regulatory guidance to project core teams and business stakeholders.
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Manage international registrations, renewals, and listings to support global market access.
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Ensure regulatory listings and shipping controls for approved products are accurate and up to date.
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Deliver regulatory support aligned with business needs and compliance requirements.
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Bachelor's degree in life sciences, engineering, or related field (advanced degree preferred).
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8+ years of regulatory affairs experience in the medical device industry .
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Strong knowledge of FDA regulations, PMA processes, and Health Canada requirements .
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Hands-on experience with Class III medical devices .
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Familiarity with international medical device regulations and product registrations.
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Excellent organizational, communication, and cross-functional collaboration skills.
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