Associate Director, QARA – Mexico & Northern Cluster

Johnson & Johnson Innovative Medicine; Bogotá ciudad; Presencial; COP 560.521.000 - 934.201.000; Jornada completa

Descripción de la vacante

Johnson & Johnson is seeking an Associate Director, QARA for Mexico/Northern Cluster. You will provide strategic leadership for quality assurance and regulatory activities across regions, ensuring regulatory compliance and sustained market access for Orthopedics.

You will collaborate with Clinical, Quality, R&D, Operations, and Commercial teams to translate requirements into practical solutions that support innovation, growth, and patient safety.

Formación

• 8–10 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device industry, with leadership responsibility.
• Proven experience with U.S. FDA and European medical device regulatory processes, including submissions and health authority interactions.
• Strong knowledge of medical device regulations, quality system requirements, and risk-based compliance principles.
• Ability to lead cross-functional teams and manage multiple QARA priorities in complex environments.
• Experience mentoring regulatory/quality professionals.

Responsabilidades

• Lead QA and Regulatory Affairs activities for Mexico and the Northern Cluster.
• Develop and execute integrated quality/regulatory strategies for registrations and approvals.
• Ensure compliance with local and international standards and the QARA policies.
• Prepare, review, and oversee regulatory submissions and technical documentation.
• Lead health authority interactions and regulatory inquiries.
• Collaborate with Clinical, Quality, R&D, Operations, and Commercial teams.
• Translate regulatory intent into actionable guidance for project teams.
• Maintain and improve QARA policies and SOPs.
• Identify quality/regulatory risks and advise leadership.

Conocimientos

Regulatory leadership

Quality systems

Cross-functional leadership

FDA regulation

EU MDR

Risk management

Mentoring

Strategic planning

Educación

Bachelor’s degree in Physical Sciences, Biological Sciences, Engineering

Advanced degree preferred (Master’s or equivalent)

Herramientas

Regulatory submissions

Quality documentation

Descripción del empleo

Johnson & Johnson is seeking an Associate Director, QARA for Mexico/Northern Cluster. You will provide strategic leadership for quality assurance and regulatory activities across regions, ensuring regulatory compliance and sustained market access for Orthopedics.

You will collaborate with Clinical, Quality, R&D, Operations, and Commercial teams to translate requirements into practical solutions that support innovation, growth, and patient safety.