TSK Laboratory · 4 days ago
Quality Assurance and Regulatory Affairs Global Manager
Irvine, CA
Full-time
Hybrid
Director/Executive
$130K/yr - $170K/yr
7+ years expTSK Laboratory operates globally in medical technologies, focusing on innovation that enhances practitioner performance and patient experience. The QARA Manager will lead and harmonize the global Quality and Regulatory program, ensuring compliance and effective quality system performance across regions.
IndustrialManufacturingMedical Device
Responsibilities
Serve as the principal advisor to the President and Executive Team on all QARA-related matters
Develop and execute a global QARA strategy aligned with corporate goals, ensuring proactive compliance and risk mitigation
Represent the QARA function in strategic planning, management reviews, and leadership meetings
Maintain and continuously improve the company’s Quality Management System (QMS) in alignment with ISO 13485, MDSAP, FDA 21 CFR Part 820, EU MDR, and other applicable international standards
Oversee internal and external audits, CAPA management, complaint handling, risk management, and product lifecycle quality
Ensure consistency in QARA processes across global facilities and teams, supporting regional regulatory submissions and site-specific compliance requirements
Lead the preparation and maintenance of regulatory documentation for product registrations, technical files, and submissions across multiple regions
Collaborate with external regulatory bodies, Notified Bodies, and competent authorities as the company’s primary QARA representative
Monitor regulatory changes and communicate impact analyses and required actions to global teams
Lead, mentor, and develop QARA team members worldwide, fostering a culture of accountability, excellence, and continuous improvement
Serve as a key mentor during onboarding for new QARA hires, ensuring knowledge transfer, consistent training, and role clarity
Promote collaboration across departments, bridging R&D, manufacturing, supply chain, and commercial functions
Establish measurable KPIs to monitor QARA effectiveness across global operations
Implement feedback mechanisms to assess system performance, onboarding success, and regulatory readiness
Drive initiatives that reduce risk, improve quality efficiency, and strengthen compliance culture across all sites
Partner with Engineering, Operations, and Supply Chain leaders to embed quality and compliance throughout the product lifecycle
Support Management Review activities with relevant data, trend analyses, and improvement recommendations
Lead communication of quality updates, audit findings, and compliance metrics to executives and relevant stakeholders
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
Minimum 7+ years of experience in Quality Assurance and Regulatory Affairs within the medical device industry
Demonstrated experience leading global QARA functions or teams across multiple regions
Strong knowledge of ISO 13485, MDSAP, FDA QSR, and EU MDR regulations
Proven success managing audits, CAPA, and post-market surveillance
Exceptional communication, leadership, and organizational skills
Experience working directly with executive leadership and cross-functional global teams
Preferred
Master's or advanced degree
Company
TSK Laboratory
TSK Laboratory is a manufacturing company that manufactures needles and medical devices.
201-500 employees
Funding
Current Stage
Growth StageRecent News
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