Associate Dir, QARA MX / N. Cluster

DePuy Synthes is recruiting for an Associate Director, Quality Assurance & Regulatory Affairs (QARA) – Mexico / Northern Cluster, located in Mexico City, Mexico or Columbia. 

The Associate Director, Quality Assurance & Regulatory Affairs (QARA) – Mexico / Northern Cluster provides strategic and operational leadership for quality assurance and regulatory affairs activities across Mexico and the Northern Cluster. This role is accountable for ensuring regulatory compliance, effective quality management system execution, and sustained market access for DePuy Synthes’ Orthopedics portfolio. 

This is a high‑impact leadership role with direct influence on product lifecycle decisions, health authority interactions, inspection readiness, and regional QARA excellence. The role partners closely with cross‑functional leaders to translate regulatory and quality requirements into practical business solutions that support innovation, growth, and patient safety. 
 

Key Responsibilities 

• Lead and coordinate Quality Assurance and Regulatory Affairs activities for new, modified, and marketed medical devices across Mexico and the Northern Cluster. 

• Develop and execute integrated quality and regulatory strategies to support product registrations, notifications, approvals, and long‑term market sustainability, including alignment with U.S. FDA and EU MDR pathways as applicable. 

• Ensure compliance with local regulatory requirements, applicable international standards, and DePuy Synthes quality management system policies and procedures. 

• Prepare, review, and oversee high‑quality regulatory submissions, technical documentation, and registration files, ensuring accuracy, completeness, and inspection readiness. 

• Lead and support 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 teams to ensure regulatory and quality readiness for clinical trials, manufacturing, and product launches. 

• Interpret and communicate regulatory and quality requirements, policies, and changes, translating regulatory intent into clear, actionable guidance for project teams. 

• Establish, maintain, and improve QARA policies, procedures, and SOPs to ensure sustained compliance and market support. 

• Identify quality and regulatory risks and opportunities and proactively advise leadership on potential business and compliance impact. 

• Mentor, coach, and develop QARA team members, building regional capability, accountability, and a strong culture of quality and compliance. 

• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth. 

Qualifications 

Education 

• Required: Bachelor’s degree in Physical Sciences, Biological Sciences, Engineering, or a related field. 

• Preferred: Advanced degree (Master’s or equivalent) in a scientific, technical, or regulatory discipline. 

Experience and Skills 

Required: 

• 8–10 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device industry, with demonstrated leadership responsibility. 

• Proven experience with U.S. FDA and European medical device regulatory processes, including submissions and health authority interactions. 

• Strong working knowledge of medical device regulations, quality system requirements, and risk‑based compliance principles. 

• Demonstrated ability to lead cross‑functional teams and manage multiple QARA priorities in complex, matrixed environments. 

• Experience mentoring or managing regulatory and/or quality professionals. 

• Strong leadership presence, sound judgment, and effective decision‑making and problem‑solving capabilities. 

Preferred: 

• Hands‑on experience supporting product approvals, inspections, audits, and regulatory issue management. 

• Experience supporting orthopedic products and/or Class II/III medical devices. 

• Demonstrated success in strategic decision‑making in highly regulated environments. 

• Prior experience managing regional or multi‑country regulatory and quality scopes. 

• Regulatory Affairs or Quality certifications (e.g., RAC or equivalent). 

• Strong written and verbal communication skills, with the ability to influence and negotiate with internal and external stakeholders. 

Other 

• Language: Fluency in English and Spanish required. 

• Travel: Moderate regional travel across LATAM markets 

• Certifications: Regulatory Affairs or Quality certifications preferred but not required. 

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.