Artivion, Inc.

Compliance

• Establish, approve, and oversee global regulatory strategies for emerging technology, product development, product registrations, lifecycle management, and market access
• Lead portfolio-level regulatory planning for complex high-risk devices, including pathways, claims, labeling, evidence, timelines, resources, and approval risk
• Serve as senior Regulatory Affairs representative to executive leadership, program governance, and cross-functional product development teams
• Advise on regulatory risk, tradeoffs, and go/no-go decisions
• Influence and manage emerging and acquired technology opportunities and support integrations
• Oversee timely, high-quality submissions to global regulatory agencies, including FDA pre-submissions, IDE, PMA, 510(k), PMA supplements, EU MDR technical documentation, CE Marking, deficiency responses, and international registrations
• Lead and negotiate regulatory authority interactions, including FDA meetings, notified body reviews, competent authority engagement, advisory panel preparation, formal correspondence, and deficiency resolution
• Advise on clinical evidence strategies supporting global approvals
• Interpret evolving global medical device regulations, standards, and guidance; assess enterprise impact and drive implementation plans
• Support global compliance programs
• Partner with R&D, Clinical, Quality, Operations, Supply Chain, Marketing, Commercial, and Legal teams
• Direct regulatory assessments for new technologies, design changes, labeling, claims, product discontinuations, partnerships, and business development opportunities
• Contribute to commercial plans and regional/corporate objectives
• Build, manage, mentor, and succession-plan the Regulatory Affairs organization; set goals, allocate resources, manage budgets, and establish metrics
• Provide senior regulatory leadership for audits, inspections, escalations, field actions, and compliance issues

Senior Director, Regulatory Affairs – Product Development

Product Manager

• Lead development and execution of the commercialization strategy for Artivion’s next-generation Endovascular Aortic Arch Repair stent graft portfolio
• Lead upstream voice of customer activities and engage external vascular surgeon customers
• Translate market needs into product opportunities and ensure concepts are market-driven and commercially viable
• Manage new product introductions through launch
• Collaborate and lead within Endo Aortic Arch and Bridging Stent cross-functional core teams
• Provide product marketing support for project milestones and deliverables
• Develop and execute voice of customer and market research initiatives
• Interface with customers and regional partners through travel, congresses, and symposia
• Partner with key opinion leaders to anticipate market changes, trends, competition, and future needs
• Support trial site selection, training, and engagement during clinical trials
• Develop and manage key opinion leader cardiac and vascular surgeon relationships
• Collaborate with Sales Leadership on commercialization and integrated marketing plans
• Develop training and marketing materials for commercial launch
• Manage the marketing budget quarterly
• Apply project management expertise