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Regulatory Affairs Specialist
hace 2 semanas
**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 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.
- Advanced English 90%
Tipo de puesto: Tiempo completo
Salario: $100.00 - $200.00 al mes
Horario:
- Lunes a viernes
Prestaciones:
- Seguro de gastos médicos mayores
