Senior Director, Regulatory Affairs – Product Development

🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟠 Senior

🚔 Compliance

👻 Geisterscore 10%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Warum dieser Wert:

• Seit 53 Tagen offen.
• Stellen bei diesem Unternehmen werden meist in 74 Tagen besetzt.
• Kein Gehalt angegeben.

Jetzt Bewerben

Deinen Lebenslauf-Score prüfen

Lebenslauf + Anschreiben anpassen

Ähnliche Remote-Jobs finden

☆ Speichern☑️ Als beworben markieren❌ Ausblenden

Problem melden

Artivion, Inc.

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 1984

🏥 Gesundheitswesen

🏭 Fertigung

💼 Beratung

Healthcare • Manufacturing • Consulting

Artivion, Inc. ist ein Medizintechnikunternehmen, das sich auf die Entwicklung, Herstellung und Vermarktung von chirurgischen Geräten und Biomaterialprodukten mit Fokus auf die Aorta und das Herz spezialisiert hat. Das Unternehmen produziert Herzklappen (On-X), Stentprothesensysteme für den Aortenbogen und thorakoabdominale Bereiche, hybride Prothesen (AMDS), kryokonservierte Allografts und Gewebe, chirurgische Klebstoffe (BioGlue) sowie ergänzende vaskuläre und kardiale chirurgische Instrumente. Artivion arbeitet mit Herz- und Gefäßchirurgen zusammen und führt klinische Studien und regulatorische Einreichungen durch, um die Sicherheit und Wirksamkeit der Geräte zu verbessern und bedient Krankenhäuser und chirurgische Zentren weltweit.

Beschreibung

• 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

🎯 Anforderungen

• 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

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen