Associate Director, QARA – Mexico & Northern Cluster

jj; Bogotá ciudad; Presencial; COP 396.092.000 - 594.138.000; Jornada completa

Descripción de la vacante

Johnson & Johnson is seeking an Associate Director, Quality Assurance & Regulatory Affairs (QARA) – Mexico / Northern Cluster, to provide strategic leadership across Mexico and the Northern Cluster. The role focuses on ensuring regulatory compliance, quality system execution, and sustained market access for DePuy Synthes’ Orthopedics portfolio.

The position requires 8–10 years of QA/Regulatory experience, and fluency in English and Spanish, with strong leadership and cross-functional

Formación

• 8–10 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Experience with U.S. FDA and European medical device regulatory processes, including submissions and health authority interactions.

Responsabilidades

• Lead QA and Regulatory Affairs activities for Mexico and the Northern Cluster.
• Develop and execute integrated QA and regulatory strategies for registrations, notifications, approvals.
• Ensure compliance with local regulatory requirements and global standards.
• Prepare, review, and oversee regulatory submissions and documentation.
• Mentor and develop QARA team members and regional capability.

Conocimientos

Quality Assurance

Regulatory Affairs

Cross-functional leadership

Regulatory submissions

FDA & EU regulations

Educación

Bachelor’s degree in Physical/Biological Sciences/Engineering

Advanced degree (Master’s or equivalent)

Descripción del empleo

Johnson & Johnson is seeking an Associate Director, Quality Assurance & Regulatory Affairs (QARA) – Mexico / Northern Cluster, to provide strategic leadership across Mexico and the Northern Cluster. The role focuses on ensuring regulatory compliance, quality system execution, and sustained market access for DePuy Synthes’ Orthopedics portfolio.

The position requires 8–10 years of QA/Regulatory experience, and fluency in English and Spanish, with strong leadership and cross-functional