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Regulatory Affairs Specialist

hace 3 meses

Ciudad Juarez, México BEPC Inc A tiempo completo

Develop and maintain regulatory strategies for the development, registration, and commercialization of medical devices
- Communicate with regulatory authorities to obtain timely approvals for medical devices
- Review and approve labeling, marketing, and promotional materials to ensure compliance with regulations
- Monitor regulatory changes and provide guidance to cross-functional teams on potential impact to business
- Participate in cross-functional teams to ensure regulatory compliance throughout the product lifecycle
- Assist with the preparation and conduct of regulatory inspections and audits
- Maintain regulatory files and ensure documentation is up-to-date and accurate

Qualifications:

- Bachelor's degree in a scientific discipline
- 3+ years of experience in Regulatory Affairs in the Medical Device industry
- Strong understanding of US and international regulations related to medical devices, including FDA, EU MDR, and other global regulations
- Experience preparing and submitting regulatory filings for medical devices
- Excellent communication, organizational, and analytical skills
- Ability to work independently and in a team environment
- Strong attention to detail and ability to manage multiple projects simultaneously.

Tipo de puesto: Tiempo completo

Horario:

- Horas extra
- Lunes a viernes

Prestaciones:

- Seguro de vida

Puede trasladarse/mudarse:

- Ciudad Juárez, Chih.: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Obligatorio)

Experiência:

- industria medica: 3 años (Obligatorio)

Idioma:

- Inglés (Obligatorio)

Lugar de trabajo: Empleo presencial