Alexander Mark
Medical Safety Manager at 4c Medical Technologies, Inc
Based in Sparrows Point, United States
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Seniority
Manager
Department
Healthcare & Human Services
Location
Sparrows Point
Industry
Biotechnology
Company size
54
Contact information
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a•••••••@4cmed.com
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Background
About Alexander Mark
Dynamic and results-driven Medical Safety Manager responsible for overseeing the safety profile of IDE medical device, ensuring compliance with regulatory requirements, and managing risk mitigation strategies throughout the product lifecycle. Expertise in structural heart disease, integrating scientific knowledge with regulatory frameworks, risk, and technology principles. Proven success in clinical trial support, key opinion leader engagement, and regulatory compliance, with a passion for advancing healthcare technologies to improve patient outcomes. Scientific expertise: • Cardiovascular devices, with a focus on heart failure therapy and treatment of vascular diseases. • Clinical trial management • Key opinion leader engagement • Scientific presentations and medical writing • Competitive intelligence • Cross-functional collaboration • Clinical training, clinical sales support • Regulatory compliance: Industry standards, DRT alignment, FDA submission processes
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