Associate Dir, QARA LATAM Ops & Distr.
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Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .
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 Santiago Santiago Metropolitan Region ChileJob 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 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 & DistributionlocatedinMexico Cityor Columbiaor 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 distributionfocused market models across Latin America as part ofInternational QARAorganization.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.
Thisposition 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 distributionbased market models in alignment with global QARA objectives and international priorities.
Ensure compliance withcountryspecific regulatory requirements distributor obligations quality management system standards and internal policies andprocedures.
Provide strategic quality and regulatory guidance to support distributorbased and operational market models across LATAM.
Serve as the senior QARA escalation point for LATAM Operations & Distribution Local Market Support
Partner with crossfunctional 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 impactstoproducts supply continuity and business operations.
Supportandas lead regulatory inspections quality audits and health authority interactions ensuringtimelyand 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: Bachelors degree in Regulatory Affairs Life Sciences Engineering ora relateddiscipline.
Preferred: Advanced degree or professional certification in Regulatory Affairs Quality ora relatedfield.
Experience and Skills
Required:
810 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 distributionbased market models.
Demonstrated experience leading multicountry QARA portfolios or complex regional market clusters.
Proven ability to develop and execute integrated quality and regulatory strategies aligned with business supply and distributionobjectives.
Strong leadership stakeholder management and decisionmaking capabilities.
Ability tooperateeffectively in a global matrixed organization.
Preferred:
Experience supportingInternationalregulatory and quality operating models.
Experience working in multinational medicaldeviceor 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; Portuguese preferred.
Travel: Moderate regional travel across LATAM markets.
Certifications: RAC or equivalent preferred but not.
For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.
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 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 internal employees contact AskGS to be directed to your accommodation resource.
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#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 ThinkingRequired Experience:
IC
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
