Medical Safety Manager – EI

🕒 2 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $133.000 - $237.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

🦅 Patrocina Visto H1B

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Philips

10.000+ funcionários

⚕️ Seguro de Saúde

🧬 Biotecnologia

Healthcare Insurance • Biotechnology • Medical Devices

Na última década, nos transformamos em uma líder focada em tecnologia em saúde.

Descrição

• Conduct comprehensive evaluations of safety information sourced from various channels • Provide essential support in Risk Management, Health Hazard Evaluations (HHE), and recall procedures • Assist in delivering safety-related perspectives for New Product Introduction (NPI) projects and clinical studies • Analyze safety data from clinical trials and post-market surveillance • Provide answers to safety-related inquiries from healthcare professionals and internal stakeholders

🎯 Requisitos

• 7+ years of experience in Medical/Clinical affairs in Medical Device/Biotech industry or equivalent • Active clinical license (Nursing or MD strongly preferred) • Strong knowledge of relevant standards and regulations for the medical device industry (ISO, IEC, etc.) • Strong knowledge and understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses • Bachelor’s/master’s degree in medical, Nursing, or equivalent (MD preferred) • Excellent communicator with ability to influence cross-functional stakeholders

🏖️ Benefícios

• Generous PTO • 401k (up to 7% match) • HSA (with company contribution) • Stock purchase plan • Education reimbursement

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