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

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Senior Platform Regulatory Specialist
Merit Medical Systems Inc. —Tijuana, B.C.
- Tiempo completo
- Licenciatura
- Mejora continua
- Liderazgo
- Seguro dental
3d
Sr Spec, IT-Global Serialization
Baxter —Guadalajara, Jal.
- Inglés
- Licenciatura
- Negociación
- Vacaciones adicionales o permisos con goce de sueldo
12d
Marketing Analyst
Convatec —Nápoles, CDMX
- Tiempo completo
- Microsoft Powerpoint
- Microsoft Excel
- Administración de personal
6d
Sr. Risk Management Engineer
Fresenius Medical Care —Reynosa, Tamps.
- Bilingüe
- Administración de personal
- Inglés
Portfolio Strategy & Planning
Eli Lilly —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Inglés
- Liderazgo
16h
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
1d
Regulatory Device CMC Manager
サイネオス・ヘルス —Tlalnepantla, Méx.
- Administración de personal
- Licenciatura
- Contratos
16h
Project Analyst
IQVIA —Ciudad de México, CDMX
17h

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Analista Químico (Con experiencia)
LABORATORIO DE CONTROL ARJ —Granjas México, CDMX
Disponibilidad para rotar turno en fines de semana. Si cuentas con tu título, cédula. Gusto y facilidad para aprendizaje. Sueldo base acorde a experiencia.
$16,000 a $18,500 por mes
Postulación rápida
14d
Químico de laboratorio
Hospitales Star Médica —Benito Juárez, CDMX
1 año de experiencia como Químico de Laboratorio en Hospitales o clínicas química clínica, uroanalisis, parasitología, etc).
$18,000 a $20,000 por mes
Postulación rápida

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Senior Platform Regulatory Specialist

Merit Medical Systems Inc. -
Tijuana, B.C.

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Información del empleo

Tiempo completo
Hace 3 días

Beneficios

Seguro dental

Cualificaciones

Licenciatura
Mejora continua
Liderazgo

Descripción completa del empleo

Work Shift:

DAY

Work Schedule:

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

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.
12. Supports and when needed represents Regulatory Affairs in audits/inspections leading to successful outcomes.
13. Performs other duties and tasks as required.

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

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.
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.

As an eligible Merit employee, you can expect the following:

Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights

Medical/Dental & Other Insurances (eligible the first of month after 30 days)

Low Cost Onsite Medical Clinic

Two (2) Onsite Cafeterias

Employee Garden | Gardening Classes

3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays

401K | Health Savings Account

To see more on our culture, go to www.merit.com/careers .

Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.

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regulatory affairs empleos

Senior Platform Regulatory Specialist

Sr Spec, IT-Global Serialization

Marketing Analyst

Sr. Risk Management Engineer

Portfolio Strategy & Planning

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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