REGULATORY AFFAIRS ASSISTANT | SERVICE LEASING

Description

Job Summary: Regulatory Affairs Assistant to provide specialized support in document and regulatory management for Medical Devices and In Vitro Diagnostic Products. Key Highlights: 1. Specialized support role in document and regulatory management 2. Focused on Medical Devices and In Vitro Diagnostic Products 3. Supports compliance with applicable technical and legal regulations We are **SIMED PERÚ**, a company with a strong track record in the healthcare sector and active presence in Peru and Ecuador. We specialize in providing cutting-edge medical technologies, contributing to the strengthening of clinical diagnostic systems and healthcare delivery across the region. Currently, we are seeking a **Regulatory Affairs Assistant** to deliver specialized support services in document and regulatory management for our portfolio of **Medical Devices and In Vitro Diagnostic Products**, ensuring compliance with current technical and legal regulations. **Scope of Service** This service includes specialized support in document and regulatory management, primarily covering: * Registration and updating of **regulatory technical documents** on the Regulatory Platform. * Preparation and organization of **technical files per health registration** for bulk upload to the Regulatory Platform. * Review of **validity, integrity, and consistency** of regulatory technical documents corresponding to SIMED’s product portfolio. * Preparation of **letters and technical documentation** for submitting inquiries to DIGEMID. * Other activities related to the scope of service that may be necessary for effective regulatory management. **Requirements** * Graduate in Pharmacy and Biochemistry. * Minimum of **1 year** of experience in Regulatory Affairs-related activities, preferably within healthcare, pharmaceutical, or medical device companies. * Knowledge of current **technical and legal regulations applicable to Medical Devices and In Vitro Diagnostic Products**. * Experience managing and handling **technical documentation for Medical Devices and In Vitro Diagnostic Products**. * Experience in **preparing and submitting technical inquiries to DIGEMID**. * Experience using **regulatory systems and platforms**. * Proficiency in managing **technical documentation databases** for Medical Devices and In Vitro Diagnostic Products. * Intermediate-level proficiency in **Microsoft Office**. * Strong organizational skills, attention to detail, and ability to track documentation. * Availability to provide services **on-site in Magdalena del Mar**. Service Conditions * **Engagement Model:** Service Leasing – Honorarium Receipt. * **Service Location:** Magdalena del Mar, Lima. * **Estimated Duration:** **3 months**, subject to service scope and requirements. * **Required Availability:** The service requires availability to perform tasks and coordination primarily between **9:00 a.m. and 6:30 p.m., Monday through Friday**. Salary: S/.1,800\.00 per month Application Question(s): * What is your academic degree? * This position is temporary, under a service leasing arrangement, with an estimated duration until December 2026\. Would you have any objections to this engagement model and service period? * Do you agree with the offered honorarium? Workplace: On-site employment