Medical Safety Manager, Hospital Patient Monitoring

🕒 Agosto 25

🏈 Alabama, Alaska, +44 estados a mais – Remoto

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💵 $133.000 - $237.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

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👻 Score fantasma 0%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Philips

10.000+ funcionários

🏥 Saúde

⚕️ Seguro de Saúde

🧬 Biotecnologia

Healthcare • Healthcare Insurance • Biotechnology

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

Descrição

• Conduct comprehensive evaluations of safety information from Post-Marketing Surveillance and literature searches • Contribute insights and recommendations to Risk Management, Health Hazard Evaluations, Risk-Benefit analyses, and recall procedures • Provide safety perspectives for New Product Introduction projects, clinical studies, and Post-Marketing Surveillance efforts • Provide safety inputs for regulatory submissions, Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports • Conduct literature reviews and surveillance activities to identify emerging safety issues • Respond to safety-related inquiries from healthcare professionals, patients, and internal stakeholders • Contribute to safety-related policies, procedures, and programs • Monitor evolving medical product safety regulations and guidelines for compliance • Provide input into safety studies and medical device vigilance activities • Analyze clinical trial and post-market surveillance data to identify safety signals and trends

🎯 Requisitos

• 5+ years of experience with a Bachelor’s degree OR minimum 3+ years of experience with a Master’s degree • Experience in Medical/Clinical affairs in the Medical Device/Biotech industry or equivalent • Critical Care and/or Telemetry experience required • Experience as a practicing clinician required • Bachelor’s/master’s degree in medical, Nursing, or equivalent • Strong knowledge of relevant medical device industry standards and regulations, including ISO and IEC • Strong knowledge of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses in a medical device environment • Ability to perform minimum physical, cognitive, and environmental job requirements with or without accommodation • Excellent communication and ability to influence cross-functional stakeholders using clinical expertise and knowledge of standard of care and medical device standards • Willingness and ability to travel up to 25% based on business needs • US work authorization required; candidates requiring current or future work-authorized visa sponsorship will not be considered

🏖️ Benefícios

• Generous PTO • 401k with up to 7% match • HSA with company contribution • Stock purchase plan • Education reimbursement • Annual incentive bonus, sales commission or long-term incentives may be offered • Company relocation benefits will not be provided

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