Analista Senior de Asuntos Regulatorios at Fresenius Medical Care

Bogota, D.C., Bogota, D.C., Colombia

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, PharmaceuticalsIndustries

Requirements

Profesional en Química Farmacéutica y/o Química
Mínimo 3 años de experiencia en cargos de regulación sanitaria
Conocimientos en Procesos regulatorios de Medicamentos y Dispositivos para humanos BPM, BPA, CCAA, Sistemas de gestión de calidad
Inglés: Intermedio Alto

Responsibilities

Llevar a cabo la recolección de información técnica y legal necesaria para obtener y/o mantener los registros sanitarios de los productos fabricados o comercializados por la compañía con el objetivo de garantizar la disponibilidad comercial de los productos y cumplir con los requerimientos regulatorios exigidos por autoridades Sanitarias
Apoyar los procesos regulatorios de la región LATAM
Realizar la revisión de las actas generadas por las Salas Especializadas de Medicamentos y Productos Biológicos y la Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro, en lo concerniente a los productos relacionados con la Compañía

Skills

Key technologies and capabilities for this role

Regulación SanitariaMedicamentosDispositivos MédicosBPMBPACCAASistemas de Gestión de CalidadInglés Intermedio Alto

Questions & Answers

Common questions about this position

What qualifications and experience are required for this role?

Candidates must be professionals in Química Farmacéutica or Química, with a minimum of 3 years of experience in regulatory health positions. Required knowledge includes regulatory processes for medications and human devices, BPM, BPA, CCAA, and quality management systems. Intermediate-High English level is necessary.

Is this a full-time position?

Yes, this is a full-time employment position.

What is the salary range for this position?

This information is not specified in the job description.

What are the main responsibilities of the Senior Regulatory Affairs Analyst?

The role involves collecting technical and legal information to obtain or maintain health registrations for company products, supporting LATAM regulatory processes, and reviewing minutes from specialized rooms for medications, biological products, medical devices, and in vitro diagnostic reagents related to the company.

What benefits are offered for this position?

This information is not specified in the job description.

Fresenius Medical Care

Provides dialysis and renal healthcare services

About Fresenius Medical Care

Fresenius Medical Care North America focuses on delivering high-quality healthcare services to individuals with kidney and other chronic conditions. The company operates a vast network of dialysis centers and outpatient labs for cardiac and vascular care, ensuring coordinated treatment for many patients across the continent. It stands out as the largest fully integrated renal company, providing not only dialysis services but also specialty pharmacy and laboratory services. Additionally, Fresenius manufactures and distributes a wide range of dialysis equipment, disposable products, and renal pharmaceuticals. The goal of Fresenius Medical Care is to enhance the quality of life for patients with chronic illnesses by providing comprehensive and accessible healthcare solutions.

Waltham, MassachusettsHeadquarters

1996Year Founded

$39.1MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

11-50Employees

Benefits

Professional Development Budget

Conference Attendance Budget

Flexible Work Hours

Risks

Increased competition from telehealth solutions like Philips' eCareManager 4.1.

Rising mental health challenges may impact FMCNA's employee productivity.

Virtual reality education may face adoption and accessibility challenges in rural areas.

Differentiation

FMCNA is the world's largest fully integrated renal company.

FMCNA offers a comprehensive line of dialysis equipment and renal pharmaceuticals.

FMCNA provides coordinated healthcare services at pivotal care points for chronic conditions.

Upsides

Telehealth market growth supports FMCNA's remote patient monitoring services.

Home dialysis market expansion aligns with FMCNA's patient-centric care approach.

AI integration enhances FMCNA's predictive analytics and personalized medicine capabilities.

Land your dream remote job 3x faster with AI

Try Jobo Free