Regulatory Affairs Specialist

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 accurateQualifications:- 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 completoHorario:- Horas extra- Lunes a viernesPrestaciones:- Seguro de vidaPuede 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