Regulatory Affairs Assistant

Description

Job Summary: We are seeking a passionate and dedicated Regulatory Affairs Assistant to support regulatory management and compliance for medical device products. Key Responsibilities: 1. Support regulatory compliance and management. 2. Preparation of dossiers for sanitary registrations and certifications. 3. Management of dossiers and coordination with foreign suppliers. We seek a passionate and dedicated **Regulatory Affairs Assistant** to join our team. This role will be responsible for supporting the management and compliance of applicable regulations and standards, ensuring legal compliance in the marketing and manufacturing of medical device products. **REQUIREMENTS:** * Bachelor's degree or graduate in Pharmacy and Biochemistry. (Mandatory) * Minimum 1 year of experience in sanitary registration of medical devices and/or pharmaceuticals. * Minimum 1 year of experience in pharmacies, pharmaceutical laboratories, and/or medical equipment sales companies. * Residence in areas near Surco. * Intermediate level of English. **RESPONSIBILITIES:** * Preparation of dossiers for modifications, extensions, changes, registration, re-registration, and updates of Sanitary Registrations and Certifications to ensure uninterrupted product commercialization and expand the company’s product portfolio. * Preparation of technical inquiries and coordination with the technical departments of foreign suppliers. * Responding to technical inquiries regarding products from the commercial department. * Conducting, maintaining, and managing dossiers. * Preparing and verifying the technical documentation required to obtain Sanitary Registration of products with DIGEMID. * Conducting quality inspections and verification of Good Practices compliance within the company. * Supporting Sanitary Registration and Re-registration processes. * Monitoring stock depletion. * Performing extensions or changes in product presentation format. * Verifying GPP compliance at assigned locations. * Tracking all matters related to product dossiers for various procedures in accordance with national and international programs. * Other duties as assigned. **SPECIFIC KNOWLEDGE:** * Knowledge of Supreme Decree 016-2011. * Knowledge of Classes 1, 2, and 3. * Basic knowledge of GMP, GPP, and GLP. * Knowledge of the VUCE system. **WORK SCHEDULE** * Monday to Friday: 7:30 AM to 4:40 PM; Saturday: 7:30 AM to 1:30 PM. **BENEFITS** * Pleasant work environment. * Opportunity to join a solid company in the sector. * Full payroll registration. Salary: S/.1,500.00 – S/.1,800.00 per month. Application Questions: * Are you available to start immediately? * Please state your salary expectations, district of residence, and WhatsApp number. * Please detail your experience with procedures at VUCE and DIGEMID, and your knowledge of medical device registration. Work Location: On-site employment