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

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Senior Platform Regulatory Specialist
Merit Medical —Tijuana, B.C.
- Tiempo completo
- Inglés
- Licenciatura
- Mejora continua
3d
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
7h
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
20h
Regulatory Device CMC Manager
サイネオス・ヘルス —Tlalnepantla, Méx.
- Administración de personal
- Licenciatura
- Contratos
7h
Project Analyst
IQVIA —Ciudad de México, CDMX
8h

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Diseñador Gráfico Freelance
Innova Talent - Soluciones Humanas —Zapopan, Jal.
*Preparar archivos finales para impresión* offset, digital y flexografía, verificando sangrados, resolución y acabados.
$500 por día
Postulación rápida
Diseñador Gráfico Freelance B2B
Ingenieria Quimica Automatica SA de CV —Los Ailes, Méx.
Somos una empresa en busca de un diseñador grafico con conocimiento en area B2B, que ayude en tareas de desarollo de catalogos y publicidad para la empresa.
$2,000 a $2,500 por semana
Postulación rápida

Quiero recibir la alerta de empleo más reciente para regulatory affairs

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Senior Platform Regulatory Specialist

Merit Medical -
Tijuana, B.C.

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Información del empleo

Tiempo completo
Hace 3 días

Cualificaciones

Inglés
Licenciatura
Mejora continua
Liderazgo

Descripción completa del empleo

Descripción y detalle de las actividades

ESSENTIAL FUNCTIONS PERFORMED

1. Collaborates with key stakeholders to ensure alignment of regulatory goals and objectives with the strategic priorities of the business.

2. Develops and maintains strong strategic partnerships with project team members, including Marketing, R&D, Operations, Clinical Affairs and Quality Assurance.

3. Ensures all regulatory activities for assigned platform and operations projects comply with evolving global regulatory requirements.

4. Maintains product knowledge within the team and ensures essential data is gathered and organized in support of global submissions.

5. Partners with the Regional RA team in the development, alignment and execution of Regulatory strategies for platform and operations projects and changes, upholding rigorous standards of accuracy, timeliness, compliance and excellence in regulatory strategy.

6. In collaboration with Regional RA, represents Merit effectively in interactions with Regulatory authorities, strengthening Merit's reputation and credibility.

7. Supports and suggests continuous improvement of regulatory processes, procedures and policies.

8. Ensures compliance with relevant regulatory requirements.

9. Ensures project teams are informed of new and pending changes in regulation and evolving interpretation of regulation and how they will be impacted.

10. Ensures the timely maintenance of regulatory data with a high degree of accuracy and compliance.

11. Supports Regulatory Affairs in due diligence activities to ensure regulatory risks and integration needs are clearly articulated and understood. Coordinates with Regional RA on the integration of new acquisitions.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

Lifting - Not to exceed 50 lbs. - local practice may apply.
Writing
Sitting
Standing
Bending
Visual acuity
Color perception
Depth perception
Reading
Field of vision/peripheral

Experiencia y requisitos

MINIMUM QUALIFICATIONS

Bachelors degree in life sciences, engineering, regulatory affairs or a related discipline.
8 years of progressive Regulatory Affairs experience in the medical device industry.
Advanced English level
Prior experience in medical industry
Prior experience with health authorities and regulatory agencies such as U.S. FDA, European Notified Bodies, and Health Canada.
Demonstrated general knowledge of global medical device regulations, and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc., Design Controls, reviewing and approving project plans, qualification protocols/reports. Modern computer skills.
Relevant regulatory certifications (e.g., RAC) strongly preferred.

COMPETENCIES

Project management
Written and Verbal Communication
Attention to Detail
Continuous Improvement
Analytical Skills
Strategic leadership
Team development
Results oriented
Integrity
Organization

COMMENTS

Infectious Control Risk Category III:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.

Beneficios

Beneficios de acuerdo a la LFT

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SOLICITAR

Número de vacantes 1

Área Ingeniería

Contrato Permanente

Modalidad Presencial

Turno Diurno

Jornada Tiempo Completo

Estudios Carrera con título profesional

Inglés Hablado: Avanzado, Escrito: Avanzado

Disponibilidad p. viajar No

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Refina tu búsqueda

regulatory affairs empleos

Senior Platform Regulatory Specialist

Diseñador Gráfico Freelance

Portfolio Strategy & Planning

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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Quiero recibir la alerta de empleo más reciente para regulatory affairs

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