Director, Quality Systems – Regulatory Affairs

🕒 Julho 6

🦌 Connecticut – Remoto

🦌 Connecticut – Remote

💵 $160.000 - $180.000 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

👻 Score fantasma 6%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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CEFALY Technology

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2004

🏥 Saúde

🍽️ Alimentos e Bebidas

💼 Consultoria

💰 Private Equity Round em 2019-08

Healthcare • Food & Beverage • Consulting

A CEFALY Technology é uma empresa de saúde dedicada a proporcionar alívio da enxaqueca sem medicamentos por meio de seu dispositivo médico aprovado pela FDA. Este dispositivo inovador, usado na testa, utiliza eletroestimulação para atingir o nervo trigêmeo, aliviando a dor aguda da enxaqueca e prevenindo futuros ataques. A CEFALY visa melhorar a qualidade de vida dos pacientes oferecendo uma alternativa eficaz e segura aos medicamentos tradicionais, permitindo que os usuários gerenciem seu tratamento de enxaqueca de forma independente, com a ajuda de um aplicativo conectado.

Descrição

• Serve as system owner and business lead for the organization’s eQMS platform including optimization, implementation expansion, workflow design, governance, and user adoption • Assess current eQMS utilization and develop a roadmap for full implementation and process maturity • Own and administer day-to-day QMS and eQMS activities and processes • Lead continual improvement initiatives across quality system processes and documentation • Lead comprehensive audits of controlled documentation and quality records to identify inconsistencies, gaps, obsolete content, and systemic documentation deficiencies • Establish processes and controls ensuring consistency across SOPs, work instructions, forms, labels, templates, and quality records • Drive document control processes including creation, revision workflows, review cycles, training assignments, archival activities, and change management • Develop sustainable document governance practices to reduce repeat nonconformances and improve inspection readiness • Monitor quality metrics and identify opportunities for process improvements • Support and improve CAPA, nonconformance, complaint handling, change control, risk management, and supplier quality processes • Ensure QMS alignment with ISO 13485, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and applicable global requirements • Lead initiatives to improve quality system effectiveness, data integrity, and organizational compliance maturity • Maintain ongoing inspection and audit readiness • Act as primary Quality and Regulatory lead during notified body audits, FDA inspections, supplier audits, and external quality assessments • Lead audit preparation strategy, evidence collection, coordination activities, and response management • Drive audit finding remediation through root cause analysis and sustainable CAPA implementation • Support management review processes and quality reporting • Maintain a continuous state of organizational inspection readiness • Independently lead FDA and international regulatory submissions and agency interactions • Prepare, coordinate, and execute regulatory filings and lifecycle submissions • Conduct regulatory impact assessments related to product, process, manufacturing, supplier, labeling, and operational changes • Provide regulatory strategy recommendations and communicate business impact to leadership. • Mentor and help develop junior QA/RA personnel • Provide quality and regulatory leadership across Operations, Supply Chain, Customer Service, Product Development, and leadership teams

🎯 Requisitos

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field required • Advanced degree preferred • 8–12+ years of progressive Quality and Regulatory Affairs experience within medical devices • Demonstrated experience serving as lead quality or regulatory representative during notified body audits and regulatory inspections • Proven experience owning, implementing, or significantly improving an electronic QMS platform; Greenlight Guru experience strongly preferred • Demonstrated experience identifying and remediating systemic documentation and quality system deficiencies • Experience independently leading FDA submissions and EU MDR activities • Experience with CAPA, complaint handling, risk management, supplier quality, document control, and change management systems • Demonstrated success improving audit outcomes and quality system maturity • Prior people leadership or mentoring experience strongly preferred • Experience supporting Class II and/or Class III medical devices preferred

🏖️ Benefícios

• Health insurance (80% employer-paid) • Employer-paid Dental and Vision • Short-Term and Long-Term Disability • Group Life Insurance • IRA with company match (no vesting period) • Paid PTO • Paid company holidays