Associate Dir, QARA MX / N. Cluster

Johnson & Johnson MedTech

Bogotá ciudad

Presencial

COP 311.400.000 - 498.241.000

Jornada completa

Hace 5 días

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Descripción de la vacante

Johnson & Johnson is seeking an Associate Director, Quality Assurance & Regulatory Affairs for the Mexico/Northern Cluster, with leadership across QARA activities and regulatory submissions. This role oversees compliance, submissions, and health authority interactions to secure ongoing market access for orthopedics products.

The position requires 8–10 years in QA/RA for medical devices, with strong FDA/EU MDR experience and hands-on leadership in a matrixed environment.

Formación

8–10 years of progressive experience in QA/RA within the medical device industry.
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.
Regulatory Affairs or Quality certifications (e.g., RAC) preferred but not required.

Responsabilidades

Lead QA 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.
Ensure compliance with local regulatory requirements, applicable international standards, and DePuy Synthes QMS policies and procedures.
Prepare, review, and oversee high-quality regulatory submissions, technical documentation, and registration files.
Lead and support health authority interactions, including pre-submission and post-submission meetings, negotiations, and 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.
Translate regulatory intent into clear, actionable guidance for project teams; mentor and develop QARA staff.
Establish, maintain, and improve QARA policies, procedures, and SOPs; identify risks and opportunities for leadership.
Shaping regional policy initiatives critical to business strategy, continuity, and growth.

Conocimientos

Regulatory affairs

Quality assurance

Leadership

Cross-functional collaboration

Regulatory submissions

Risk-based compliance

Regulatory strategy

Communication

Problem solving

Mentoring

Educación

Bachelor’s degree in Physical Sciences, Biological Sciences, Engineering, or related field

Master’s or equivalent advanced degree preferred

Herramientas

Regulatory certifications (RAC) preferred

Descripción del empleo

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 Group

Job Sub Function

Regulatory Affairs

Job Category

People Leader

All Job Posting Locations:

Bogotá, Distrito Capital, Colombia

Job 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) – 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.

Required

Experience and Skills

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.

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.

#DePuySynthesCareers

Required Skills