Regulatory Affairs Specialist

Empresa socia de Amedirh solicita "REGULATORY AFFAIRS SPECIALIST"**REQUIREMENTS/QUALIFICATIONS**- Bachelor´s Degree in biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, and engineering- English fluently**WORK EXPERICENCE**:- +10 years in the presentation of technical dossiers in the field of medical devices to the authorities of the Ministry of Health.**REQUIRED KNOWLEDGE**:- In-depth familiarity with ISO 13485, 10993, 14971 standards.- Experience in professional writing of regulatory documents in the field of medical devices or OTC drugs.- Independent learning ability.- Experience in writing documents and submitting 510K files to the FDA.- Knowledge of MDR regulation.**RESPONSIBILITES**:- Prepare technical dossiers for registration in the USA, Europe and other international markets.- Submit technical dossiers for registration in USA, Europe and other international markets.- Follow up on new guidelines worldwide and support from the regulatory aspect to all company activities.- Drafting regulatory documents in the field of medical devices or OTC drugs (510 K).**BENEFITS**:$60,000 - $65,000 MXN per month + IMSS + Paid vacations + Grocery vouchersTipo de puesto: Tiempo completo, Por tiempo indeterminadoSalario: $60,000.00 - $65,000.00 al mesBeneficios:- Vacaciones superiores a las de ley- Vales de despensa