Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
Bogotá, Distrito Capital, Colombia, Juarez, Chihuahua, MexicoJob Description:
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.DePuy Synthes is recruiting for an Associate Director, Quality Assurance & Regulatory Affairs (QARA) – LATAM Operations & Distribution, located in Mexico City or Columbia or Brazil
The Associate Director, Quality Assurance & Regulatory Affairs (QARA) – LATAM Operations & Distribution provides strategic and operational leadership for quality assurance and regulatory affairs supporting operations‑ and distribution‑focused market models across Latin America as part of International QARA organization. This role is accountable for ensuring regulatory compliance, effective quality management system execution, distributor governance, and sustained market access across diverse and complex LATAM markets.
This position plays a critical leadership role in enabling reliable supply, business continuity, and patient safety. The Associate Director partners closely with Regulatory Affairs, Quality, Supply Chain, Commercial, and Global QARA teams to manage quality and regulatory risk and support compliant growth.
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.
Experience working in multinational medical device or healthcare organizations.
Exposure to regulatory inspections, quality audits, and health authority negotiations in Latin America.
Demonstrated success driving QARA transformation, process improvement, or operational simplification initiatives.
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.
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.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
#DePuySynthesCareers
Required Skills:
Preferred Skills:
Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Managing Managers, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic ThinkingDePuy Synthes is recruiting for an Associate Director, Quality Assurance & Regulatory Affairs (QARA) – LATAM Operations & Distribution, located in Mexico City or Columbia or Brazil
The Associate Director, Quality Assurance & Regulatory Affairs (QARA) – LATAM Operations & Distribution provides strategic and operational leadership for quality assurance and regulatory affairs supporting operations‑ and distribution‑focused market models across Latin America as part of International QARA organization. This role is accountable for ensuring regulatory compliance, effective quality management system execution, distributor governance, and sustained market access across diverse and complex LATAM markets.
This position plays a critical leadership role in enabling reliable supply, business continuity, and patient safety. The Associate Director partners closely with Regulatory Affairs, Quality, Supply Chain, Commercial, and Global QARA teams to manage quality and regulatory risk and support compliant growth.
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.
Experience working in multinational medical device or healthcare organizations.
Exposure to regulatory inspections, quality audits, and health authority negotiations in Latin America.
Demonstrated success driving QARA transformation, process improvement, or operational simplification initiatives.
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.
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.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
#DePuySynthesCareers
