Stark Pharma Solutions Inc
Regulatory Affairs Product Manager
Stark Pharma Solutions Inc, New York, New York, United States
Position:
Regulatory Affairs Product Manager
Location:
Kennesaw, GA (Hybrid)
Experience Required:
8+ years Overview
Our client is seeking an experienced
Regulatory Affairs Product Manager
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. Support and maintain Canadian medical device licenses. Conduct regulatory impact assessments for product and process changes. Develop, maintain, and track PMA-related documentation and regulatory deliverables. Provide regulatory guidance to project core teams and business stakeholders. Manage international registrations, renewals, and listings to support global market access. Ensure regulatory listings and shipping controls for approved products are accurate and up to date. Deliver regulatory support aligned with business needs and compliance requirements. Qualifications
Bachelor's degree in life sciences, engineering, or related field (advanced degree preferred). 8+ years of regulatory affairs experience in the medical device industry. Strong knowledge of FDA regulations, PMA processes, and Health Canada requirements. Hands-on experience with Class III medical devices. Familiarity with international medical device regulations and product registrations. Excellent organizational, communication, and cross-functional collaboration skills. We are an equal opportunities employer and welcome applications from all qualified candidates.
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Regulatory Affairs Product Manager
Location:
Kennesaw, GA (Hybrid)
Experience Required:
8+ years Overview
Our client is seeking an experienced
Regulatory Affairs Product Manager
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. Support and maintain Canadian medical device licenses. Conduct regulatory impact assessments for product and process changes. Develop, maintain, and track PMA-related documentation and regulatory deliverables. Provide regulatory guidance to project core teams and business stakeholders. Manage international registrations, renewals, and listings to support global market access. Ensure regulatory listings and shipping controls for approved products are accurate and up to date. Deliver regulatory support aligned with business needs and compliance requirements. Qualifications
Bachelor's degree in life sciences, engineering, or related field (advanced degree preferred). 8+ years of regulatory affairs experience in the medical device industry. Strong knowledge of FDA regulations, PMA processes, and Health Canada requirements. Hands-on experience with Class III medical devices. Familiarity with international medical device regulations and product registrations. Excellent organizational, communication, and cross-functional collaboration skills. We are an equal opportunities employer and welcome applications from all qualified candidates.
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