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Regulatory Affairs Specialist I
Merit Medical —Tijuana, B.C.
- Tiempo completo
- Word processing
- Inglés
- Licenciatura
7h

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Regulatory Affairs Specialist I
Merit Medical —Tijuana, B.C.
Demonstrated knowledge of regulatory affairs. Participates on project task teams. Education and/or experience equivalent to a Bachelor's Degree and two years of…
7h

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Regulatory Affairs Specialist I

Merit Medical -
Tijuana, B.C.

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Información del empleo

Tiempo completo
Hace 7 horas

Cualificaciones

Word processing
Inglés
Licenciatura
Uso de computadora
Habilidades de comunicación

Descripción completa del empleo

Descripción y detalle de las actividades

This position is responsible to coordinate and help prepare document packages for regulatory submissions, internal audits, governmental inspections, recalls, Medical Device Reports and clinical trials.

ESSENTIAL FUNCTIONS PERFORMED

1. Coordinates and prepares document packages for:

Regulatory submissions (domestic and international)
Facilitates corrective actions on internal audits
Governmental inspections
Recalls
Medical Device Reports
Clinical trials
Company policies and procedures

2. Interacts, as directed, with various levels of management, external agencies and companies.

3. Participates on project task teams.

4. Performs other related duties and tasks, as required.

Experiencia y requisitos

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

SUMMARY OF MINIMUM QUALIFICATIONS

Education and/or experience equivalent to a Bachelor's Degree and two years of related experience or six years of regulatory experience.
Advanced English level (must)
Demonstrated knowledge of regulatory affairs.
Demonstrated human relations and effective communication skills.
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
Strong organizational skills and the ability to be self-motivated and be detailed oriented.

COMPETENCIES

Document packaging and coordination for:
Regulatory submissions (domestic and international)
Facilitates corrective actions on internal audits
Governmental inspections
Recalls
Medical Device Reports
Clinical trials
Company policies and procedures
Management/external agency/company interaction.
Project task team participation

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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Regulatory Affairs Specialist I

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