Governance, Risk, and Compliance Manager

🕒 Abril 22

🏄 California – Remoto

info

💵 $120.000 - $140.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

🚔 Conformidade

🦅 Patrocina Visto H1B

info

🗣️🇺🇸🇬🇧 Inglês obrigatório

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TigerConnect

201 - 500 funcionários

TigerConnect é a plataforma de comunicação mais amplamente adotada na área da saúde, modernizando de forma única a colaboração entre médicos, enfermeiros, equipes de cuidado e pacientes. A TigerConnect é a única solução que combina uma experiência de usuário similar à de consumidores para comunicação clínica e com pacientes, com elevados requisitos de segurança, privacidade e fluxos de trabalho clínicos que as organizações de saúde exigem atualmente. A TigerConnect acelera a produtividade, reduz custos e melhora os resultados dos pacientes.

Descrição

• Maintain and support certifications and registrations including FDA, SOC 2, HITRUST, and ISO 27001 control environments. • Coordinate annual audits, evidence collection, and remediation tracking. • Support FDA and QMS program: Develop, maintain , and manage the Quality Management System (QMS), including document control, record management, and change control processes. • Plan and conduct internal QMS audits; support external audits, ensuring evidence is organized and audit-ready. • Support product clearances, approvals, and ongoing product compliance activities. • Administer complaint handling processes and manage product surveillance activities. • Coordinate field actions (e.g., recalls, corrections) as required , including regulatory notifications and effectiveness checks. • Coordinate training programs tied to QMS procedures and FDA-regulated activities. • Track corrective and preventive actions (CAPAs) and drive timely closure. • Track and report compliance metrics and control status. • Partner with Legal and Security on annual risk assessments, risk tracking and remediation.

🎯 Requisitos

• 7+ years of experience in Quality Assurance, Regulatory Affairs, compliance, or GRC within a healthcare or medical device environment. • Experience supporting SOC 2, HITRUST, FDA, and/or ISO environments. • Experience managing compliance within a HIPAA regulated environment is a plus. • Hands-on experience with QMS administration (e.g., document control, CAPAs, training records) in an FDA-regulated or healthcare SaaS environment preferred. • Relevant certifications helpful (e.g., CIPP, CIPM, CHPC, CISA). • Bachelor’s degree in a technical field (e.g., engineering, life sciences, computer science) or equivalent experience. • Trained ISO 13485 lead auditor certification highly desirable; willingness to obtain certification is acceptable. • Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint); experience with Confluence, JIRA, and Azure DevOps preferred. • Strong written and verbal communication skills with the ability to translate complex regulatory requirements into actionable procedures. • Ability to develop expertise across all aspects of TigerConnect’s quality management system post-hire.

🏖️ Benefícios

• Excellent Medical, Dental, and Vision insurance for you and your family plus a 401k match • Focus on your well-being through our wellness reimbursement program and company-wide wellness days (extra days off to rest and recharge) • Our flexible time off lets you work hard and play hard—on your schedule • Join a mission-driven team committed to making a real impact in the world of healthcare

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