Senior Regulatory Affairs Program Lead – MedTech Surgery

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🕒 Setembro 30

🏄 California – Remoto

🏄 California – Remote

💵 $125.000 - $201.250 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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Johnson & Johnson

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

💊 Farmacêutico

🧬 Biotecnologia

Healthcare • Pharmaceuticals • Biotechnology

<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

• Lead regulatory strategy development and execution for the OTTAVA robotic systems portfolio • Prepare and execute regulatory strategies for NPD and LCM projects • Serve as strategic regulatory lead across product development, submission, approval, and LCM activities • Act as regulatory subject matter expert for electromechanical devices with software-enabled functionality • Review and provide regulatory feedback on specifications, device testing, risk management, labeling, and related documentation • Prepare, write, and file FDA submissions, including Q-submissions, IDEs, De Novo submissions, and 510(k)s • Lead FDA meeting preparation • Execute sustaining activities, including change assessments, Letters to File, registrations, and renewals • Support technical documents for global health authority submissions • Apply expert knowledge of relevant guidances, regulations, and standards • Support audits • Work closely with engineering and clinical teams to support product development and submission-ready documentation • Support health authority communications

🎯 Requisitos

• Minimum of a Bachelor’s degree required • At least 6+ years of regulatory affairs experience in medical devices, including experience with software-enabled systems • Proven track record of securing regulatory approvals, such as 510(k)s, IDEs, and De Novos • Highly collaborative and flexible; comfortable navigating ambiguity • Excellent cross-functional communication and ability to influence within regulatory and across functions • Independent strategic thinking and ability to synthesize guidances, regulations, and trends into regulatory strategy • Advanced problem-solving skills • Experience evaluating new regulatory requirements and regulatory changes for project impact • Experience leading multiple complex projects • Experience supporting the US market • May require up to 10% travel • Preferred: previous health authority meeting experience and preparation • Preferred: experience with vision systems, robotics, and connected medical platforms • Preferred: experience with IEC 60601 series and ISO 10993-1 • Preferred: strong knowledge of FDA software and cybersecurity regulatory requirements

🏖️ Benefícios

• Retirement plan (pension) • Savings plan (401(k)) • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington • Holiday pay, including Floating Holidays – 13 days per calendar year • Work, 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