Senior Director, Regulatory Affairs - Product Development

Position Overview: The Senior Director Regulatory Affairs, Product Development will be responsible for setting enterprise-level global regulatory strategy for Artivion's new product development portfolio and leading the regulatory approach for complex, high-risk medical device programs from early feasibility through approval, launch and lifecycle expansion. This role will lead senior Regulatory Affairs management and staff, serve as a senior regulatory decision-maker for assigned programs and represent Artivion with global regulatory authorities, notified bodies and other external stakeholders. The position is accountable for anticipating regulatory risk, resolving complex submission and agency issues, and ensuring clear, timely and compliant regulatory execution across regions.

Responsibilities: Establish, approve and oversee global regulatory strategies for emerging technology, product development, product registrations, lifecycle management and market access with domestic and international regulatory agencies. Lead portfolio-level regulatory planning for complex high-risk devices, including regulatory pathway, claims, labeling, evidence, timelines, resource plans and approval risk. Serve as the 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, as needed. Oversee and ensure timely, high-quality submissions to global regulatory agencies, including US FDA pre-submissions, IDE, PMA, 510(k), PMA supplements, EU MDR technical documentation, CE Marking, deficiency responses and international strategies for registration. Lead, prepare for and negotiate regulatory authority interactions, including FDA meetings, notified body reviews, competent authority engagement, advisory panel preparation, formal correspondence and complex deficiency resolution. Advise on clinical evidence strategies to support global approvals, including IDE/pivotal study design alignment, endpoints, follow-up expectations, post-approval commitments, real-world evidence and benefit-risk framing. Interpret current and evolving global medical device regulations, standards and guidance; assess enterprise impact and drive implementation plans that support compliant innovation and market access. Support global compliance programs. Partner with R&D, Clinical, Quality, Operations, Supply Chain, Marketing, Commercial and Legal to integrate regulatory requirements into design controls, manufacturing changes, labeling, promotional claims, launch readiness and pre- & post-market commitments. Direct regulatory assessments for new technologies, design changes, labeling and claims, product discontinuations, development partnerships and business development opportunities, as applicable. Contribute to commercial plans and advise on strategies to achieve regional and corporate objectives. Build, manage, mentor and succession-plan a high-performing Regulatory Affairs organization; set goals, allocate resources, manage budgets and establish metrics and processes that align with business objectives. Provide senior regulatory leadership for audits, inspections, escalations, field actions and compliance issues; maintain the highest standards of ethics, regulatory compliance and patient safety.

Qualifications: Bachelor's degree required in science, engineering, life sciences or related discipline; advanced degree in a relevant focus area preferred. Minimum 12 years of experience in regulatory affairs or the medical device industry with bachelor's degree, including significant leadership experience, ORMinimum 10 years of experience in regulatory affairs or the medical device industry with engineering degree and master's degree, including significant leadership experience. Extensive experience defining and executing global regulatory strategies for Class II/III and high-risk medical devices across new product development and lifecycle management. Proven success leading or substantially influencing successful submissions and approvals, including IDE, PMA, HDE, PMA supplements, EU MDR technical documentation/CE Marking and international registrations such as ANVISA, PMDA, and Health Canada. Knowledge of and expertise in global medical device regulations, particularly US FDA, EU MDR, Canada, Latin America and Asia Pacific requirements. Experience leading direct interactions and negotiations with FDA, notified bodies and global regulatory authorities, including pre-submissions, deficiency responses, advisory panel preparation and inspection support. Demonstrated ability to align regulatory strategy with clinical evidence generation, pivotal studies, benefit-risk assessments, labeling, claims and commercialization plans. Experience with global quality system regulations and standards, including US FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, design controls and related medical device standards. Strong executive communication, influencing, negotiation and stakeholder management skills in complex, matrixed environments. Advanced analytical thinking skills; ability to understand principles of engineering, physiology, device design, medical device use and software/digital components, as applicable. Proven program and portfolio management skills with ability to assess, prioritize and complete multiple complex projects, tasks and responsibilities. Advanced personnel development, succession planning, budget/resource management and organizational design skills. High ethical standards, sound judgment and ability to lead through ambiguity while maintaining compliance, quality and patient safety focus.

Requisition Number: SENIO002546Job Category: Regulatory Affairs

Schedule: Full-Time