TSK Laboratory
Quality Assurance & Regulatory Affairs Manager
TSK Laboratory, Irvine, California, United States, 92713
Quality Assurance & Regulatory Affairs Manager
TSK Group operates globally in medical technologies, focusing on innovation that supports both practitioner performance and patient experience through constant iteration, smart engineering, and attention to detail.
About the Role The QA/RA Manager plays a pivotal leadership role in driving the company’s global Quality Assurance and Regulatory Affairs strategy. Reporting directly to the President, this position ensures that TSK Group’s Quality Management System (QMS) and regulatory compliance standards are harmonized and effective across all global operations. The role oversees a team of approximately 10‑12 QA/RA professionals and acts as the bridge between executive leadership and global QA/RA teams.
Key Responsibilities Strategic Leadership
Serve as the principal advisor to the President and Executive Team on all QA/RA‑related matters.
Develop and execute a global QA/RA strategy aligned with corporate goals, ensuring proactive compliance and risk mitigation.
Represent the QA/RA function in strategic planning, management reviews, and leadership meetings.
Global Quality Management
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 QA/RA processes across global facilities and teams, supporting regional regulatory submissions and site‑specific compliance requirements.
Regulatory Affairs & Compliance
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 QA/RA representative.
Monitor regulatory changes and communicate impact analyses and required actions to global teams.
Lead, mentor, and develop QA/RA team members worldwide, fostering a culture of accountability, excellence, and continuous improvement.
Serve as a key mentor during onboarding for new QA/RA hires, ensuring knowledge transfer, consistent training, and role clarity.
Promote collaboration across departments, bridging R&D, manufacturing, supply chain, and commercial functions.
Performance Monitoring & Continuous Improvement
Establish measurable KPIs to monitor QA/RA 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.
Cross‑Functional Collaboration
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.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s or advanced degree preferred).
Minimum 7+ years of experience in Quality Assurance and Regulatory Affairs within the medical device industry.
Demonstrated experience leading global QA/RA 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.
Compensation & Benefits
Competitive salary within the range of USD 120,000 to USD 160,000.
Extended healthcare: medical, dental, and vision.
15 days paid time off.
Company‑issued devices such as laptop and mobile phone.
Bonus and raises based on performance and succession execution of key metrics.
Why Join Us We’re a team focused on delivering real value to our customers and investing in the growth of our people. If you are energized by solving problems, streamlining processes, and making a difference for customers and our team every day, we want to hear from you.
Equal Opportunity Employer We value diversity and are an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
Seniority Level Director
Employment Type Full‑time
Job Function Legal
Industries Medical Device
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About the Role The QA/RA Manager plays a pivotal leadership role in driving the company’s global Quality Assurance and Regulatory Affairs strategy. Reporting directly to the President, this position ensures that TSK Group’s Quality Management System (QMS) and regulatory compliance standards are harmonized and effective across all global operations. The role oversees a team of approximately 10‑12 QA/RA professionals and acts as the bridge between executive leadership and global QA/RA teams.
Key Responsibilities Strategic Leadership
Serve as the principal advisor to the President and Executive Team on all QA/RA‑related matters.
Develop and execute a global QA/RA strategy aligned with corporate goals, ensuring proactive compliance and risk mitigation.
Represent the QA/RA function in strategic planning, management reviews, and leadership meetings.
Global Quality Management
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 QA/RA processes across global facilities and teams, supporting regional regulatory submissions and site‑specific compliance requirements.
Regulatory Affairs & Compliance
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 QA/RA representative.
Monitor regulatory changes and communicate impact analyses and required actions to global teams.
Lead, mentor, and develop QA/RA team members worldwide, fostering a culture of accountability, excellence, and continuous improvement.
Serve as a key mentor during onboarding for new QA/RA hires, ensuring knowledge transfer, consistent training, and role clarity.
Promote collaboration across departments, bridging R&D, manufacturing, supply chain, and commercial functions.
Performance Monitoring & Continuous Improvement
Establish measurable KPIs to monitor QA/RA 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.
Cross‑Functional Collaboration
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.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s or advanced degree preferred).
Minimum 7+ years of experience in Quality Assurance and Regulatory Affairs within the medical device industry.
Demonstrated experience leading global QA/RA 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.
Compensation & Benefits
Competitive salary within the range of USD 120,000 to USD 160,000.
Extended healthcare: medical, dental, and vision.
15 days paid time off.
Company‑issued devices such as laptop and mobile phone.
Bonus and raises based on performance and succession execution of key metrics.
Why Join Us We’re a team focused on delivering real value to our customers and investing in the growth of our people. If you are energized by solving problems, streamlining processes, and making a difference for customers and our team every day, we want to hear from you.
Equal Opportunity Employer We value diversity and are an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
Seniority Level Director
Employment Type Full‑time
Job Function Legal
Industries Medical Device
#J-18808-Ljbffr