Associate Director, Quality Assurance & Regulatory Affairs (QARA) – LATAM Operations & Distribution Location: Mexico City or Colombia or Brazil Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob Category: People LeaderAll Job Posting Locations: Bogotá, Distrito Capital, Colombia, Juarez, Chihuahua, Mexico Key Responsibilities Lead and oversee Quality Assurance and Regulatory Affairs strategy and execution for LATAM operations‑ and distribution‑based market models in alignment with global QARA objectives and international priorities. Ensure compliance with country‑specific regulatory requirements, distributor obligations, quality management system standards, and internal policies and procedures. Provide strategic quality and regulatory guidance to support distributor‑based and operational market models across LATAM. Serve as the senior QARA escalation point for LATAM Operations & Distribution Local Market Support. Partner with cross‑functional stakeholders including Commercial, Quality, Supply Chain, Legal, and Global QARA to ensure compliant supply, distributor oversight, and sustained market access. Monitor regulatory, quality, and operational changes across LATAM markets and assess potential impacts to products, supply continuity, and business operations. Support and, as required, lead regulatory inspections, quality audits, and health authority interactions, ensuring timely and effective responses. Drive continuous improvement, simplification, and harmonization of QARA processes supporting LATAM operations and distribution models. Lead, coach, and develop QARA talent, fostering a strong culture of quality, compliance, accountability, and performance. Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth. Define distributor markets and design processes and systems that enable an efficient Distribution Management structure. Qualifications Education Required: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline. Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field. Experience and Skills Required: 8–10 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device, healthcare, or other highly regulated industries. Strong working knowledge of LATAM regulatory requirements and operations‑ or distribution‑based market models. Demonstrated experience leading multi‑country QARA portfolios or complex regional market clusters. Proven ability to develop and execute integrated quality and regulatory strategies aligned with business, supply, and distribution objectives. Strong leadership, stakeholder management, and decision‑making capabilities. Ability to operate effectively in a global, matrixed organization. Preferred: Experience supporting International regulatory and quality operating models, multinational medical device or healthcare organizations, regulatory inspections, quality audits, and health authority negotiations in Latin America. Regulatory Affairs or Quality certification (e.g., RAC or equivalent). Other Language: English and Spanish required; Portuguese preferred. Travel: Moderate regional travel across LATAM markets. Certifications: RAC or equivalent preferred but not required. Equal Employment Opportunity Johnson & 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. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr