Senior Manager Quality Assurance & Regulatory Affairs
Summary
Responsibilities
- Lead end-to-end project management for medical device development, from concept through FDA clearance or approval and U.S. market launch
- Create, maintain, and manage integrated product roadmaps, timelines, budgets, and resource plans in a fast-paced startup environment with shifting priorities
- Design and execute quality assurance frameworks and regulatory compliance programs, including FDA 510(k), PMA, IDE, pre-submission processes, drug approvals, and INDs
- Ensure full compliance with FDA regulations, ISO standards, and other applicable requirements, including IRB, HRP, clinical study protocols, and animal research regulations (IACUC, OLAW, ACURO)
- Oversee internal and external audits, regulatory inspections, and certification activities
- Manage regulatory submissions and maintain accurate, compliant documentation throughout the product lifecycle
- Partner cross-functionally to embed quality and regulatory best practices across development, clinical, and commercialization activities
- Lead, develop, and mentor quality assurance, regulatory, and safety teams to support organizational objectives
- Track evolving regulatory requirements and proactively update company policies, processes, and procedures
Qualifications
- Bachelor's or Master's degree in engineering, life sciences, or a related discipline
- 10+ years of experience in quality assurance and regulatory affairs roles
- 5+ years of leadership experience managing teams, projects, and operational processes
- Strong communication, leadership, and strategic planning capabilities
FAQs
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