Associate Director, Quality Assurance & Regulatory Affairs (QARA) – Mexico / Northern Cluster (MedTech)

Location: Hybrid role based in Bogotá, Colombia, or Mexico City, Mexico. Moderate regional travel across LATAM markets is required.

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions; the Orthopaedics business is planned to become the standalone DePuy Synthes company.

What you will do

• Lead Quality Assurance and Regulatory Affairs activities for new, modified, and marketed medical devices across Mexico and the Northern Cluster.
• Develop and execute quality and regulatory strategies supporting product registrations, notifications, approvals, and long-term market access.
• Prepare and oversee regulatory submissions, technical documentation, registration files, and inspection-readiness activities.
• Lead health authority interactions, including pre-submission and post-submission meetings, negotiations, and responses to regulatory inquiries.
• Partner with Clinical, Quality, R&D, Operations, Supply Chain, and Commercial functions to support clinical trials, manufacturing, and product launches.
• Mentor and develop QARA professionals while advising leadership on regulatory risks, opportunities, policies, and business impact.

Requirements

• Bachelor’s degree in Physical Sciences, Biological Sciences, Engineering, or a related field; an advanced scientific, technical, or regulatory degree is preferred.
• 8–10 years of progressive Quality Assurance and/or Regulatory Affairs experience in the medical device industry, including leadership responsibility.
• Experience with U.S. FDA and European medical device regulatory processes, submissions, and health authority interactions.
• Strong knowledge of medical device regulations, quality systems, and risk-based compliance principles.
• Demonstrated ability to lead cross-functional teams, manage multiple priorities, make sound decisions, and solve problems in complex matrixed environments.
• Fluency in English and Spanish is required.

Nice to have

• Experience with orthopedic products and Class II/III medical devices.
• Experience supporting product approvals, inspections, audits, and regulatory issue management.
• Experience managing regional or multi-country regulatory and quality scopes.
• Regulatory Affairs or Quality certification, such as RAC or equivalent.

Culture & Benefits

• Inclusive work environment focused on respect, diversity, dignity, and employee development.
• Opportunity to influence product lifecycle decisions, patient safety, innovation, and regional QARA excellence.
• Role includes moderate regional travel across LATAM markets.
• Employment may transition to DePuy Synthes following completion of the planned Orthopaedics separation, subject to legal and regulatory requirements.