Associate Director, QARA – Mexico & Northern LATAM

J&J Family of Companies; Bogotá; Presencial; COP 496.229.000 - 628.556.000; Jornada completa

Descripción de la vacante

Johnson & Johnson is seeking an Associate Director, Quality Assurance & Regulatory Affairs (QARA) for the Mexico/Northern Cluster. Based in LATAM, you will drive regulatory and quality readiness for clinical trials, manufacturing and product launches, while leading a regional team to ensure sustained market access and compliance.

The role emphasizes strong leadership, partnerships with regulatory authorities, and shaping regional policy initiatives to support business growth.

Formación

• 8–10 years of progressive QA/Regulatory Affairs experience in medical devices.
• Strong knowledge of U.S. FDA and EU MDR processes and interactions.
• Proven ability to lead cross‑functional teams in regulatory projects.

Responsabilidades

• Lead QA and regulatory activities for new, modified, and marketed devices across LATAM.
• Develop and execute regulatory strategies for registrations, approvals, and ongoing compliance.
• Ensure compliance with local and international standards and the QARA policy framework.
• Prepare and review regulatory submissions and technical documentation with accuracy.
• Lead health authority interactions, including pre/post submissions and inquiries.
• Collaborate with Clinical, Quality, R&D, Operations, and Commercial teams to ensure readiness for trials and launches.

Conocimientos

QARA experience

Medical devices

Regulatory submissions

FDA & EU MDR

Leadership

Educación

Bachelor's degree in Physical/ Biological Sciences or Engineering

Descripción del empleo

Johnson & Johnson is seeking an Associate Director, Quality Assurance & Regulatory Affairs (QARA) for the Mexico/Northern Cluster. Based in LATAM, you will drive regulatory and quality readiness for clinical trials, manufacturing and product launches, while leading a regional team to ensure sustained market access and compliance.

The role emphasizes strong leadership, partnerships with regulatory authorities, and shaping regional policy initiatives to support business growth.