QA​/RA Manager

The QA/RA Manager plays a pivotal leadership role in driving the company’s global Quality Assurance and Regulatory Affairs (QA/RA) 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 individual will oversee a team of approximately 10-12 QA/RA professionals.

This role acts as the bridge between executive leadership and global QA/RA teams, ensuring alignment between strategic business goals, product quality, and regulatory compliance. The QA/RA Manager oversees quality system performance, manages international compliance activities, supports audits and certifications, and mentors a distributed team of quality and regulatory professionals. Your mission is to ensure all Quality team members are productive and effective in their respective projects and you will lead the team with clarity, autonomy, and momentum.

The TSK Group operates globally in medical technologies. Our focus is on innovation that supports both practitioner performance and patient experience—through constant iteration, smart engineering, and attention to detail. With operations across multiple global sites, we work as a close-knit, fast-moving team that values clarity, responsiveness, and accountability in everything we do.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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…