Post Market Surveillance Manager – Medical Devices

🕒 Julho 29

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $100.000 - $118.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of Owens & Minor

Owens & Minor

10.000+ funcionários

Fundada em 1882

📦 Logística

💼 Consultoria

🏥 Saúde

💰 Post-IPO Debt em 2022-03

Logistics • Consulting • Healthcare

Owens & Minor é uma empresa global de soluções em saúde que fornece produtos e serviços essenciais para apoiar o cuidado desde o hospital até a casa. A empresa é especializada em logística de saúde, gerenciamento de inventário, soluções de cadeia de suprimentos e prevenção de infecções. Ela oferece soluções logísticas para reduzir custos e eliminar complexidades tanto em ambientes de saúde agudos quanto não agudos. Owens & Minor também atua em consultoria, ajudando a melhorar cadeias de suprimentos de saúde e parcerias. A empresa é dedicada a capacitar provedores de saúde e servir pacientes, fabricantes e comunidades com sua gama de produtos e serviços.

Descrição

• The Manager is responsible for establishing an efficient and effective global program to audit quality systems and compliance areas such as FCPA and an effective and compliant Post Market Surveillance (PMS) program. • Manages and maintains an Owens & Minor Global QARAC Audit program. • Harmonizes QARA and Compliance internal audit processes across Owens & Minor to meet customer and regulatory requirements; continuously monitored and improved; execute proficient auditors using appropriate audit protocols. • Manages and maintains an Owens & Minor Global PMS program to meet customer and regulatory requirements. • Responsible for identifying and facilitating a team of qualified, independent internal QARAC auditors. • Maintains a centralized log of all internal and third party audits, findings and status of responses. • Conducts proactive data analysis and promotes a culture of continuous improvement to identify opportunities and improve the Owens & Minor global quality and compliance systems.

🎯 Requisitos

• Must have experience with FDA reporting and compliance specifically with medical devices. • Experience managing a team. • Minimum 4-5 years experience. • Bachelor's Degree. • Medical devices experience (required).

🏖️ Benefícios

• Comprehensive Healthcare Plan - Medical, dental, and vision plans start on day one of employment for full-time teammates. • Educational Assistance - We offer educational assistance to all eligible teammates enrolled in an approved, accredited collegiate program. • Employer-Paid Life Insurance and Disability - We offer employer-paid life insurance and disability coverage. • Voluntary Supplemental Programs – We offer additional options to secure your financial future including supplemental life, hospitalization, critical illness, and other insurance programs. • Support for your Growing Family – Adoption assistance, fertility benefits (in medical plan) and parental leave are available for teammates planning for a family. • Health Savings Account (HSA) and 401(k) - We offer these voluntary financial programs to help teammates prepare for their future, as well as other voluntary benefits. • Paid Leave - In addition to sick days and short-term leave, we offer holidays, vacation days, personal days, and additional types of leave – including parental leave. • Well-Being – Also included in our offering is a Teammate Assistance Program (TAP), Calm Health, Cancer Resources Services, and discount programs – all at no cost to you.

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