Regulatory Affairs Assistant

Description

Position Summary: SIMED PERÚ is seeking a Regulatory Affairs Assistant to manage sanitary registrations and ensure regulatory compliance for medical technology. Key Responsibilities: 1. Management and tracking of sanitary registrations for medical products. 2. Ensuring compliance with current legal and regulatory requirements. 3. Support in Good Storage and Distribution Practices. At **SIMED PERÚ**, we have a strong track record in the healthcare sector and an active presence in Peru and Ecuador. We specialize in providing cutting-edge medical technologies that contribute to strengthening clinical diagnosis and healthcare delivery across the region. We are currently seeking top talent to join our team as: **Regulatory Affairs Assistant.** **Position Mission** To manage and monitor the acquisition and maintenance of sanitary registrations and registration certificates for in vitro diagnostic reagents within our product portfolio, ensuring compliance with current legal regulations. Additionally, to provide support in adhering to Good Storage Practices (GSP), Good Distribution and Transportation Practices (GDTP), and Quality Assurance processes. **Requirements:** * Bachelor's or professional degree in Pharmaceutical Chemistry (regency not required) * Minimum 1 year of experience in Sanitary Registrations for Medical Devices and In Vitro Diagnostic Reagents (registrations, re-registrations, modifications, transfers of sanitary registrations, etc.) * Familiarity with current DIGEMID regulations (Supreme Decree No. 010-97, Supreme Decree No. 014-2011, Supreme Decree No. 016-2011 and their amendments) * Ability to prepare and submit technical inquiries to DIGEMID * Up-to-date technical knowledge in Regulatory Affairs * Knowledge of public procurement processes with government entities * Knowledge of Pharmacovigilance, ISO 9001. * Technical knowledge of GSP and GDTP * Proficiency in performance indicators * Proficiency in basic-to-intermediate Microsoft Office * Valid certifications in GSP and GDTP * Dynamic individual capable of teamwork, working under pressure, clear communication, responsibility, initiative, and commitment * Willingness to work on-site in the district of Magdalena del Mar * Assist the Technical Director in achieving company objectives **Offered:** * Formal employment contract with all statutory benefits * 100% coverage of the Additional Plan under EPS insurance from the start of employment * Statutory profit-sharing ***Our company promotes socio-labor inclusion of persons with disabilities. Our job opportunities are open to all individuals, regardless of gender identity, sexual orientation, ethnic origin, religion, age, disability, and/or other personal characteristics.*** Salary: S/.2,000.00 - S/.2,600.00 per month Application Questions: * How many years of experience do you have in similar roles? * What is your academic degree and profession? * What are your salary expectations? Work Location: On-site employment