Coordinador de Asuntos Regulatorios, Calidad y Director Técnico at Abbott

Buenos Aires City, Buenos Aires Autonomous City, Argentina

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Carrera profesional de Farmacia, contando con la licencia farmacéutica activa y disponible para vinculación como Co-Director/a Técnico/a
Más de 5 años de experiencia en roles similares en la industria de la salud
Inglés intermedio - avanzado
Conocimiento avanzado en Office y conocimiento en Power BI

Responsibilities

Actuar como Co-DT ante ANMAT y el Ministerio de Salud de la Provincia de Buenos Aires y representar técnicamente a la empresa frente a las autoridades regulatorias
Monitorear y analizar cambios regulatorios locales, comunicando su impacto a los stakeholders internos
Notificar inspecciones, auditorías y visitas formales a las partes interesadas
Asegurar el cumplimiento del etiquetado conforme a los requisitos locales y revisar documentos y procedimientos regulatorios locales
Firmar documentación regulatoria como Co-DT y presentar dossiers ante ANMAT
Posible soporte regulatorio a Uruguay (modelo de servicio compartido)
Apoyar el reporte de eventos médicos y acciones de campo
Inspeccionar, revisar y liberar productos
Aprobar dossiers de etiquetado/stickering y láser
Recibir, almacenar y controlar materiales promocionales y no promocionales
Hacer seguimiento de la dispensación de pedidos del programa de acondicionamiento con el operador logístico
Monitorear el cumplimiento de GMP local, políticas internacionales de calidad y calidad de servicios de 3PL
Recibir inspecciones y reportar resultados

Skills

Regulatorios

ANMAT

Calidad

Cumplimiento

Etiquetado

Auditorías

Inspecciones

Diabetes Care

Documentación Regulatoria

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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