Director, Quality Systems & Regulatory Affairs (Remote - East Coast)
$16,000–$180,000 year
HybridDarien, Connecticut, United States
Job Summary
Own and administer the organization's electronic Quality Management System (eQMS), optimizing workflows, governance, and user adoption while developing a roadmap for full implementation. Lead comprehensive audits of controlled documentation to identify gaps and drive root cause analysis for sustainable CAPA implementation. Act as the primary lead during notified body audits, FDA inspections, and supplier assessments, managing evidence collection and finding remediation. Independently manage FDA and international regulatory submissions, including lifecycle filings, impact assessments, and post-market activities aligned with ISO 13485, FDA QSR, and EU MDR. Mentor junior QA/RA personnel and provide cross-functional leadership across Operations, Supply Chain, Product Development, and customer service teams to ensure scalable growth and compliance excellence.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field
- 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
- 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
- Deep understanding of ISO 13485, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and related global regulations
- Strong understanding of quality systems architecture and eQMS administration
- Excellent technical writing and documentation skills
- Strong project management and organizational capabilities
- Strong leadership presence during audits and external interactions
- Ability to manage multiple priorities within fast-paced environments
- Excellent communication and cross-functional influencing skills
- Strong analytical, problem-solving, and systems-thinking abilities
- Remote or Hybrid - East Coast ONLY
Desired Qualifications
- Advanced degree
- Greenlight Guru experience
- Prior people leadership or mentoring experience
- Experience supporting Class II and/or Class III medical devices
- RAC, CQE, CQA, ASQ certifications, or equivalent
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