Regulatory Compliance at Abbott

Santiago, Santiago Metropolitan Region, Chile

Abbott Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, PharmaceuticalsIndustries

Requirements

  • Título de Químico Farmacéutico o carrera afín
  • Experiencia mínima de 3 años en cargos similares, en áreas de Aseguramiento de Calidad
  • Deseable manejo de inglés hablado y escrito

Responsibilities

  • Desarrollar, implementar y mantener políticas y procedimientos de cumplimiento regulatorio
  • Supervisar el cumplimiento de normativas vigentes nacionales e internacionales
  • Monitorear cambios legislativos y evaluar su impacto en las diferentes áreas de la compañía
  • Participar en auditorías internas y externas, dando soporte al área regulatoria
  • Gestionar las métricas del área regulatoria para el sistema de calidad de la compañía (CAPA’s, NC’s, desvíos, controles de cambio)
  • Asegurar la trazabilidad y control documental de productos y procesos
  • Capacitar al personal cuando aplique en procedimientos del área regulatoria y cumplimiento normativo

Skills

Regulatory Compliance
Quality Assurance
GMP
Regulatory Affairs
Policy Development
Risk Management
Pharmaceutical Regulations

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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