Regulatory Affairs Specialist I

hace 2 semanas

Tijuana, México Merit Medical Systems Inc. A tiempo completo

Why Merit?

En Merit Medical, nuestra misión es desarrollar dispositivos médicos innovadores que mejoren vidas. Nuestro objetivo es integrar y desarrollar a gente que quiere construir a través de trabajo duro, en equipo y comprometido, dispositivos que salvan vidas. Juntos estamos haciendo la diferencia en la vida de pacientes de todo el mundo.

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.

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.
- 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

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.

Como integrante de Merit, eres elegible a:
Seguro de vida, gastos médicos mayores y gastos funerarios.
Servicio médico en planta extensivo a familia.
Días de aguinaldo, vacaciones y prima vacacional superiores a los de ley.
2 días de permiso con goce al año (1 de cumpleaños y 1 día flotante) *.
2 días adicionales de festivo (viernes santo y navidad).
Fondo de ahorro sin tope.
Bono anual por resultados.
Comida gratis.
Academia Merit - Capacitación constante.
Comité de Responsabilidad Social.

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