Director, Quality Systems – Regulatory Affairs

This is a fully remote position, open to applicants in Connecticut.

📋 Description

• Act as the system owner and business leader for the organization’s eQMS platform, focusing on optimization, implementation expansion, workflow design, governance, and user adoption.

• Evaluate current eQMS usage and create a roadmap for comprehensive implementation and process maturity.

• Manage daily QMS and eQMS activities and processes.

• Spearhead continual improvement initiatives throughout quality system processes and documentation.

• Conduct thorough audits of controlled documentation and quality records to detect inconsistencies, gaps, obsolete content, and systemic documentation issues.

• Develop processes and controls to ensure uniformity across SOPs, work instructions, forms, labels, templates, and quality records.

• Oversee document control processes, including creation, revision workflows, review cycles, training assignments, archival activities, and change management.

• Create sustainable document governance practices aimed at reducing repeat nonconformances and enhancing inspection readiness.

• Track quality metrics and pinpoint opportunities for process enhancements.

• Assist in enhancing CAPA, nonconformance, complaint handling, change control, risk management, and supplier quality operations.

• Ensure QMS compliance with ISO 13485, FDA Quality System Regulation (21 CFR Part 820/QMSR), EU MDR, and relevant global standards.

• Drive initiatives to boost quality system effectiveness, data integrity, and organizational compliance maturity.

• Maintain a constant state of readiness for inspections and audits.

• Serve as the primary Quality and Regulatory lead during notified body audits, FDA inspections, supplier audits, and external quality evaluations.

• Direct audit preparation strategy, evidence collection, coordination activities, and response management.

• Facilitate audit finding remediation through root cause analysis and sustainable CAPA implementation.

• Assist in management review processes and quality reporting.

• Sustain a continuous state of organizational inspection readiness.

• Independently manage FDA and international regulatory submissions and communications with agencies.

• Prepare, coordinate, and execute regulatory filings and lifecycle submissions.

• Conduct assessments of regulatory impacts regarding product, process, manufacturing, supplier, labeling, and operational modifications.

• Offer regulatory strategy advice and convey business implications to leadership.

• Mentor and support the development of junior QA/RA personnel.

• Provide quality and regulatory leadership across Operations, Supply Chain, Customer Service, Product Development, and leadership teams.

⛳️ Requirements

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or a related field is required.

• An advanced degree is preferred.

• 8–12+ years of progressive experience in Quality and Regulatory Affairs within the medical devices sector.

• Proven experience serving as the lead quality or regulatory representative during notified body audits and regulatory inspections.

• Demonstrated capability in owning, implementing, or significantly enhancing an electronic QMS platform, with Greenlight Guru experience strongly preferred.

• Proven track record in identifying and remedying systemic documentation and quality system deficiencies.

• Experience in independently leading FDA submissions and EU MDR activities.

• Familiarity with CAPA, complaint handling, risk management, supplier quality, document control, and change management systems.

• Documented success in improving audit outcomes and the maturity of quality systems.

• Prior experience in people leadership or mentoring strongly preferred.

• Experience supporting Class II and/or Class III medical devices is preferred.

🏝️ Benefits

• Health insurance (80% employer-paid).

• Employer-paid Dental and Vision coverage.

• Short-Term and Long-Term Disability benefits.

• Group Life Insurance.

• IRA with company matching (no vesting period).

• Paid PTO.

• Paid company holidays.