OverviewJohnson & Johnson is recruiting for an Associate Director, Quality Assurance & Regulatory Affairs (QARA) for the Mexico / Northern Cluster.This leadership role provides strategic and operational leadership for quality assurance and regulatory affairs activities across Mexico and the Northern Cluster as part of the planned separation of the Orthopaedics business into De Puy Synthes.Key ResponsibilitiesLead 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 De Puy 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.Ensure proactive engagement and shaping of regional policy initiatives critical to business strategy, continuity, and growth.QualificationsBachelor's degree in Physical Sciences, Biological Sciences, Engineering, or a related field (Master's or equivalent preferred).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.Hands‐on experience supporting product approvals, inspections, audits, and regulatory issue management (preferred).
Experience supporting orthopedic products and/or Class II/III medical devices (preferred).
Strong written and verbal communication skills, with the ability to influence and negotiate with internal and external stakeholders.Regulatory Affairs or Quality certifications (e.g., RAC or equivalent) preferred.Other RequirementsTravel: Moderate regional travel across LATAM markets.Fluency in English and Spanish required.Certifications: Regulatory Affairs or Quality certifications preferred but not required.EEO StatementJohnson & Johnson is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.Johnson & Johnson actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

📌 Associate Dir, Qara Mx / N. Cluster (Chihuahua)
🏢 8283-EES S.A de C.V. Legal Entity
📍 Chihuahua