Regulatory Affairs Specialist

**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 completoSalario: $100.00 - $200.00 al mesHorario:- Lunes a viernesPrestaciones:- Seguro de gastos médicos mayores