18 publicaciones de empleo destacadas en regulatory affairs (¡Están contratando!)

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Especialista Regulatorio (7112)
Avanos —Nogales, Son.
- Microsoft Excel
- Microsoft Outlook
- Mantenimiento
Commercial Director
Bracco —Tlalpan, CDMX
- Tiempo completo
- Microsoft Powerpoint
- Microsoft Excel
- Administración de personal
Product Manager (Mexico City)
BeiGene —City, Hgo.
- Tiempo completo
- Administración de personal
- Doctorado
- Experiencia en ventas
Litigation Counsel
DiDi Global —Cuauhtémoc, CDMX
- Inglés
Diseñador Gráfico Freelance
Innova Talent - Soluciones Humanas —Zapopan, Jal.
- $500 por día
- Por temporada
- Licenciatura
- Trabajo desde casa
Postulación rápida
Portfolio Strategy & Planning
Eli Lilly —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Inglés
- Liderazgo
9h
Marketing Analyst
Convatec —Nápoles, CDMX
- Tiempo completo
- Microsoft Powerpoint
- Microsoft Excel
- Administración de personal
6d
Sr Spec, IT-Global Serialization
Baxter —Guadalajara, Jal.
- Inglés
- Licenciatura
- Negociación
- Vacaciones adicionales o permisos con goce de sueldo
12d
Sr. Risk Management Engineer
Fresenius Medical Care —Reynosa, Tamps.
- Bilingüe
- Administración de personal
- Inglés
Sr Product Manager - Biosimilars
Abbott Laboratories —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Mercadotecnia
- Inglés
10d
Sr Associate - Consumer Digital Ecosystem
Eli Lilly —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Inglés
- Disponible para viajar
13d
Technical Services Analyst
Kemin —Zapopan, Jal.
- Tiempo completo
- Ingeniería
- Inglés
- Licenciatura
Senior Clinical Data Engineer (LATAM)
Precision Medicine Group —Desde casa
- Home Office (Desde casa)
- Administración de personal
- Inglés
- SQL
Packaging Engineer 3
Fresenius Medical Care —Reynosa, Tamps.
- Bilingüe
- Inglés
- Licenciatura
Senior Clinical Data Engineer (LATAM)
Precision for Medicine —Desde casa
- Home Office (Desde casa)
- Administración de personal
- Inglés
- SQL
Postulación rápida
Senior Business Controller, International Business (flexible location)
ABB Inc. —Desde casa
- Home Office (Desde casa)
- Microsoft Excel
- Inglés
- Maestría
Postulación rápida
22h
Regulatory Device CMC Manager
サイネオス・ヘルス —Tlalnepantla, Méx.
- Administración de personal
- Licenciatura
- Contratos
9h
Project Analyst
IQVIA —Ciudad de México, CDMX
9h

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Especialista Regulatorio (7112)

Avanos -
Nogales, Son.

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Información del empleo

Cualificaciones

Microsoft Excel
Microsoft Outlook
SAP
Mantenimiento
Inglés
Licenciatura
SharePoint

Descripción completa del empleo

JOB POSITION PURPOSE

As an individual contributor, the function of the Regulatory Affairs Specialist is to support the Regulatory Affairs Department ensuring compliance with company standards and the applicable US and international medical device/drug regulations in which the company does business. The individual will prepare product submission documentation, evaluate design/manufacturing changes for effects on regulatory filings, and provide guidance to project teams as it relates to application of regulatory requirements. The individual will execute tasks and play a consultative role by partnering across internal business functions. The individual may also have/lead discussions with Regulatory Bodies.

ROLES AND RESPONSIBILITIES

SOP development and review
Lead development of regional regulatory strategy and update strategy based upon regulatory changes with limited supervision
Determine and communicate submission and approval requirements
May participate in risk-benefit analysis for regulatory compliance
Understand business environment
Self-motivated and willingness to learn and proactively problem solve
Ability to work an 8 hour day
Understanding compliance to Corporate and Regulatory procedures/ requirements and goals
New product registrations, assessing changes to existing registrations, and maintaining registrations current for assigned products/geographies
Demonstrate a strong degree of knowledge in excel spreadsheet maintenance, use of outlook tools, sharepoint, SAP based systems, and other computer programs used for tracking and reference.
Maintain records and documents for established systems that support regulatory activities and requirements.
Strong attention to detail, highly organized, and able to manage multiple projects simultaneously.
Lead projects/initiatives.
Develop and remain current on applicable internal procedures/process(s) and applicable regulations (US and INTL).

REQUIRED QUALIFICATIONS

EDUCATION: A Bachelor´s degree in a relevant discipline

EXPERIENCIE: 2-6 years of experience in the medical device industry and/or Regulatory Affairs for medical devices.

ENGLISH: Advanced

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regulatory affairs empleos

Especialista Regulatorio (7112)

Commercial Director

Product Manager (Mexico City)

Litigation Counsel

Diseñador Gráfico Freelance

Portfolio Strategy & Planning

Marketing Analyst

Sr Spec, IT-Global Serialization

Sr. Risk Management Engineer

Sr Product Manager - Biosimilars

Sr Associate - Consumer Digital Ecosystem

Technical Services Analyst

Senior Clinical Data Engineer (LATAM)

Packaging Engineer 3

Senior Clinical Data Engineer (LATAM)

Senior Business Controller, International Business (flexible location)

Regulatory Device CMC Manager

Project Analyst

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