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