Artivion, Inc.
1001 - 5000 employees
Founded 1984
🧬 Biotechnology
🤝 B2B
Biotechnology • B2B
Artivion, Inc. is a medical technology company focused on developing, manufacturing, and commercializing aortic- and cardiac-centric surgical devices and biomaterial products. The company produces heart valves (On-X), aortic arch and thoracoabdominal stent graft systems, hybrid prostheses (AMDS), cryopreserved allografts and tissues, surgical adhesives (BioGlue), and ancillary vascular and cardiac surgical tools. Artivion works with cardiac and vascular surgeons and conducts clinical trials and regulatory submissions to advance device safety and efficacy, serving hospitals and surgical centers globally.
Senior Project Manager, Global Regulatory Intelligence
🕒 April 8
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Artivion, Inc.
1001 - 5000 employees
Founded 1984
🧬 Biotechnology
🤝 B2B
Biotechnology • B2B
Artivion, Inc. is a medical technology company focused on developing, manufacturing, and commercializing aortic- and cardiac-centric surgical devices and biomaterial products. The company produces heart valves (On-X), aortic arch and thoracoabdominal stent graft systems, hybrid prostheses (AMDS), cryopreserved allografts and tissues, surgical adhesives (BioGlue), and ancillary vascular and cardiac surgical tools. Artivion works with cardiac and vascular surgeons and conducts clinical trials and regulatory submissions to advance device safety and efficacy, serving hospitals and surgical centers globally.
📋 Description
• Monitor, gather, and analyze global regulatory changes and trends • Provide insights that ensure compliance and support strategic decision-making • Track regulations and standards, triage changes for assessment and tasks • Assess impact on business operations and advise internal teams on compliance • Collaborate with global teams as a regulatory Subject Matter Expert (SME)
🎯 Requirements
• Bachelor's degree in science, engineering or related field • Minimum of 4 years of regulatory, quality, and/or compliance experience in medical device or biologics • Experience with FDA Class II or III devices or EU Class IIa/IIb or III devices • Strong analytical, technical writing, communication, organizational, project management, time management and interpersonal relationship skills • Awareness of global regulatory affairs, product development and total product lifecycle processes • Experience working with cross-functional teams • Proficiency with regulatory intelligence databases and monitoring tools, and general office software
🏖️ Benefits
• Health insurance • Flexible work arrangements • Professional development opportunities
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