Senior Project Manager, Global Regulatory Intelligence

🔥 26 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

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Artivion, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1984

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

Healthcare • Manufacturing • Consulting

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, analyze, and interpret global regulatory developments, including regulations, guidelines, standards, and legislation • Identify, mitigate, and manage regulatory or compliance risks • Communicate new and upcoming regulatory changes and facilitate their interpretation • Assess impacts on business operations and provide actionable insights to internal stakeholders • Drive internal review and implementation with subject matter experts • Manage regulatory intelligence tools, databases, and information resources • Maintain expertise in worldwide regulatory requirements and relationships with agency personnel and industry organizations • Collaborate with functional partners to update regulatory and compliance documentation and procedures • Act as a Regulatory Subject Matter Expert and provide strategic guidance • Collaborate with quality, clinical, legal, operations, R&D, and other cross-functional teams • Lead complex technical projects and manage competing priorities • Train others on regulatory systems and tools • Advise on process improvements and lead assigned improvements to completion • Support regulatory submissions and track and report regulatory actions and submissions • Participate in inspections, audits, and post-audit corrective actions • Maintain and update regulatory processes and SOPs • Support quality system programs including CAPAs, NCRs, audits, PMS, and Risk Management

🎯 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 • Experience interpreting and applying new regulations, legislation, standards, or guidelines • 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 • Ability to analyze complex information and translate it into meaningful intelligence • Proficiency with regulatory intelligence databases, monitoring tools, and general office software • Experience working with cross-functional teams • Ability to comprehend engineering, physiology, and medical device use principles • Ability to manage and prioritize numerous projects and responsibilities • Flexibility, adaptability, initiative, and willingness to lead regulatory projects • Project management experience • Expertise in Microsoft Office Suite • Preferred: Experience with US FDA, Notified Body interaction, Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices, and/or human tissue

🏖️ Benefits

• Equal Opportunity Employer • Accessibility accommodation available for applicants with disabilities