Cagent Vascular · 1 day ago
Director of Quality Assurance and Regulatory Affairs
Wayne, PA
Full-time
Onsite
Director/Executive
12+ years expCagent Vascular is seeking a Director of Quality Assurance and Regulatory Affairs to oversee and improve the company’s Quality Management System and lead regulatory strategy. This role is critical in ensuring compliance with regulatory requirements while fostering a culture of quality excellence across the organization.
Health CareMedicalMedical Device
Hiring Manager
Peter K. Johansson, P.E.
Responsibilities
Define and execute the company-wide quality strategy aligned with corporate growth
Serve as the owner of the QMS across the organization
Establish quality objectives, KPIs, and governance structures to drive accountability and continuous improvement
Advise executive leadership on quality risks, trends, and mitigation strategies
Oversee all QMS elements including document control, CAPA, complaints, change management, training, and risk management
Ensure compliance with FDA QSR, ISO 13485, and applicable international regulations
Drive QMS scalability to support increased product complexity, volume, and global expansion
Ensure consistent execution of quality processes across internal teams and external partners
Serve as primary lead for FDA inspections, notified body audits, and international regulatory audits
Oversee audit preparedness, execution, and response activities, including remediation plans and follow-up reporting
Oversee internal audit programs and supplier audit strategy
Maintain strong working relationships with regulatory bodies and external auditors
Oversee supplier quality management, including qualification, performance monitoring, and corrective actions
Partner with Manufacturing, Operations, and Engineering to ensure robust process validation and production quality
Support technology transfers, scale-up activities, and ongoing manufacturing troubleshooting
Ensure effective quality oversight of contract manufacturers and critical suppliers
Oversee complaint handling, field action assessments, and post-market surveillance activities
Monitor product performance trends, failure investigations, and root cause analyses
Ensure timely and effective corrective and preventive actions that protect patients and customers
Oversee all quality-related training programs and ensure workforce compliance
Build, develop, and lead a high-performing quality organization
Foster a proactive quality culture emphasizing accountability, ownership, and continuous improvement
Support cross-functional quality education and engagement across the company
Qualification
Required
12–18+ years of quality leadership experience in medical devices or regulated life sciences industries
Demonstrated success leading enterprise-level Quality Management Systems
Extensive experience with FDA inspections, ISO 13485 audits, and global regulatory requirements
Strong understanding of manufacturing quality, supplier quality, and process validation (IQ/OQ/PQ)
Proven ability to lead, scale, and mentor quality organizations in high-growth environments
Excellent executive communication, influence, and cross-functional leadership skills
Bachelor's degree required
Preferred
advanced degree or professional certification (e.g. ASQ, RAC) preferred
Company
Cagent Vascular
Cagent Vascular develops a serration technology for improving the treatment of cardiovascular disease.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$66.87MKey Investors
Trinity CapitalU.S. Venture Partners
2025-02-20Series Unknown· $15M
2024-02-20Series C· $30M
2021-06-23Series Unknown· $9.5M
Leadership Team
Brian Walsh
Chairman & Chief Executive Officer
Robert M. Giasolli
Founder, CTO, and VP of Research and Development
Recent News
Morningstar.com
2025-10-09
Google Patent
2025-05-04
Google Patent
2025-05-04
Company data provided by crunchbase