Senior Director, Regulatory Affairs – Product Development

Artivion, Inc.

. Establish, approve, and oversee global regulatory strategies for emerging technology, product development, product registrations, lifecycle management, and market access .

Posted 9/23/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in global regulatory strategies for high-risk medical devices, including extensive experience with FDA submissions, EU MDR compliance, and cross-functional collaboration. Proven leadership in regulatory affairs, personnel development, and strategic alignment with clinical evidence generation.

Highest-signal resume keywords

Global Regulatory Strategy DevelopmentFDA Submission ExpertiseEU MDR ComplianceLeadership in Regulatory AffairsCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsMedical Device RegulationsGlobal SubmissionsClinical Evidence StrategiesPortfolio ManagementRisk AssessmentQuality Management SystemsISO 13485Design ControlsAnalytical Thinking

Soft Skills

LeadershipMentoringDecision-MakingJudgmentCommunication

Industry Keywords

Class II/III Medical DevicesPMAIDECE MarkingANVISAPMDAHealth CanadaLifecycle ManagementCompliance ProgramsRegulatory Authority Interactions

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor's degree required in science, engineering, life sciences or related discipline
Minimum 12 years of experience in regulatory affairs or the medical device industry with bachelor's degree, including significant leadership experience, OR minimum 10 years of experience 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, ANVISA, PMDA, and Health Canada registrations
Expertise in global medical device regulations, particularly US FDA, EU MDR, Canada, Latin America, and Asia Pacific requirements
Experience leading interactions and negotiations with FDA, notified bodies, and global regulatory authorities
Ability to align regulatory strategy with clinical evidence generation, pivotal studies, benefit-risk assessments, labeling, claims, and commercialization plans
Experience with US FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, design controls, and related medical device standards
Advanced analytical thinking and understanding of engineering, physiology, device design, medical device use, and software/digital components
Proven program and portfolio management skills
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