Senior Regulatory Affairs Program Lead – MedTech Surgery

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🕒 Junho 12

🏄 California – Remoto

🏄 California – Remote

💵 $125.000 - $201.250 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Johnson & Johnson

SiteLinkedInTodas as Vagas

10.000+ funcionários

💊 Farmacêutico

🧬 Biotecnologia

🧘 Bem-estar

Pharmaceuticals • Biotechnology • Wellness

<Johnson & Johnson> é uma empresa global de saúde que pesquisa, desenvolve, fabrica e comercializa produtos farmacêuticos, dispositivos médicos e produtos de saúde para consumidores. A empresa foca em medicamentos e terapias inovadoras nas áreas de oncologia, imunologia, neurociência e cardiopulmonar, além de desenvolver soluções MedTech em cardiovascular, ortopedia, cirurgia e visão. A Johnson & Johnson também atua na educação para saúde e bem-estar, fabricação em larga escala, atividades para investidores e iniciativas de impacto social global.

Descrição

• Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator. • Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals. • Prepares and submits regulatory information required to obtain global market access. • Write and file FDA submissions (e.g., Q-submissions, IDEs, 510(k)s). • Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams. • Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status. • Guide conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials. • Assists in the development and enhancement of Regulatory Affairs processes.

🎯 Requisitos

• Minimum of a Bachelor's Degree required • Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required • Experience with Class II medical device regulatory product submissions required • Previous experience with health authority meetings/interactions required • A demonstrated track record of developing and driving implementation of regulatory strategies. • Working knowledge of Cybersecurity regulations, requirements for software as a medical device, including devices with AI/ML. • Working knowledge of requirements for medical devices that include electronic components and associated testing (IEC 60601). • Excellent communication skills for effective collaboration with cross-functional partners. • Strong attention to detail. • Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.

🏖️ Benefícios

• Pension and savings plan (401(k)) • Vacation –120 hours per calendar year • Sick time - 40 hours per calendar year • Holiday pay, including Floating Holidays –13 days per calendar year • Personal and Family Time - up to 40 hours per calendar year • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year • Caregiver Leave – 80 hours in a 52-week rolling period • Volunteer Leave – 32 hours per calendar year • Military Spouse Time-Off – 80 hours per calendar year