Director, Quality Systems – Regulatory Affairs

🕒 vor 2 Monaten

🦌 Connecticut – Remote

🦌 Connecticut – Remote

💵 $160.000 - $180.000 / Jahr

⏰ Vollzeit

🔴 Experte

🚔 Compliance

👻 Geisterscore 4%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

Jetzt Bewerben

Ähnliche Remote-Jobs finden

E-Mail-Benachrichtigung für neue Jobs einrichten

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen

CEFALY Technology

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

Gegründet 2004

🏥 Gesundheitswesen

🍽️ Lebensmittel & Getränke

💼 Beratung

💰 Private Equity Round im 2019-08

Healthcare • Food & Beverage • Consulting

CEFALY Technology ist ein Gesundheitsunternehmen, das sich der medikamentenfreien Linderung von Migränekopfschmerzen durch sein von der FDA zugelassenes medizinisches Gerät widmet. Dieses innovative Gerät, das auf der Stirn getragen wird, nutzt Elektrostimulation, um den Trigeminusnerv zu stimulieren, akute Migräneschmerzen zu lindern und zukünftige Anfälle zu verhindern. CEFALY zielt darauf ab, die Lebensqualität der Patienten zu verbessern, indem es eine effektive und sichere Alternative zu herkömmlichen Medikamenten bietet und es den Nutzern ermöglicht, ihre Migränebehandlung mit Hilfe einer verbundenen App selbständig zu steuern.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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