Global QA/RA Manager — Medical Devices

TSK Laboratory Europe B.V.; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Extended healthcare

401(k) program

15 days paid time off

Company-issued devices

Performance bonuses

Job summary

A global medical technology company is seeking a QA/RA Manager to drive its Quality Assurance and Regulatory Affairs strategy. Reporting to the President, the role involves overseeing a team of QA/RA professionals, managing compliance across global operations, and ensuring that the Quality Management System meets international standards. Candidates should have at least 7 years of experience in the medical device industry, strong regulatory knowledge, and proven leadership abilities. Attractive benefits include a competitive salary and extended healthcare.

Qualifications

• 7+ years of experience in Quality Assurance and Regulatory Affairs within the medical device industry.
• Demonstrated experience leading global QA/RA functions or teams.
• Strong knowledge of ISO 13485, MDSAP, and FDA regulations.

Responsibilities

• Develop and execute a global QA/RA strategy aligned with corporate goals.
• Oversee internal and external audits, CAPA management, and risk management.
• Lead the preparation of regulatory documentation for product registrations.

Skills

Leadership

Communication

Regulatory knowledge

Risk management

Quality management systems

Education

Bachelor’s degree in Engineering or Life Sciences

Master’s or advanced degree

Job description

A global medical technology company is seeking a QA/RA Manager to drive its Quality Assurance and Regulatory Affairs strategy. Reporting to the President, the role involves overseeing a team of QA/RA professionals, managing compliance across global operations, and ensuring that the Quality Management System meets international standards. Candidates should have at least 7 years of experience in the medical device industry, strong regulatory knowledge, and proven leadership abilities. Attractive benefits include a competitive salary and extended healthcare.