Tijuana, Baja California- Beneficios de acuerdo a la LFT
Corporativo
Giro
Manufacturera
Actividad principal
Merit medical is a leading manufacturer of medical devices.
Número de empleados
1300
Sitio Web corporativo
Sitio Web
Solicita este puesto directamente a través de nuestro portal
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
Solicita este puesto directamente a través de nuestro portal
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