REGULATORY AFFAIRS ASSISTANT - TECHNICAL DIRECTORATE

Description

Job Summary: We are seeking a talented Technical Directorate Assistant to join the Zmart Works team and collaborate in improving patients' quality of life by applying expertise in pharmacy and regulatory affairs. Key Highlights: 1. Join a great team in the medical sector. 2. Collaborate to improve patients' quality of life. 3. Opportunity for training and professional development. Are you ready to demonstrate all your capabilities and become part of a great team? Zmart Works belongs to the Química Europea Group and consists of innovators. We specialize in marketing high-quality medical equipment and supplies. Our corporate purpose is to intelligently assist society and build a trustworthy supply chain. At Zmart Works, we are seeking a talented and passionate Technical Directorate Assistant to join our team and collaborate in improving the quality of life of patients using our products in hospitals and private clinics nationwide. Join us and become part of Team Zmart, demonstrating your knowledge and developing your skills! Requirements: * Bachelor's Degree in Pharmacy and Biochemistry. * Knowledge of Good Storage Practices, Regulatory Affairs for pharmaceutical establishments (Pharmacies), Medical Devices: Current health regulatory framework (DIGEMID) and standards: ISO 13485, MDR 745/2017 EU, IMDRF. * Knowledge of Quality Management Systems, Safety, Occupational Health, and Environmental Management. * Intermediate English proficiency. * Minimum 2 years of experience. * On-site work. * Working hours: Monday to Friday, 8:00 AM to 6:00 PM. Tasks where you will demonstrate your skills: · Support registration, re-registration, minor and major changes, and stock depletion of sanitary registrations. · Support in drafting procedures and updating formats. · Verification of Good Storage Practices (GSP) at authorized warehouses. · Assist in verifying compliance with storage conditions. · Review logistics processes regarding traceability from receipt, storage, and distribution to customers. · Support reviewing imports at our warehouses. · Support audits conducted by DIGEMID. · Archive documentation related to the department. · Other duties as assigned by the immediate supervisor. · Evaluate stages of the regulatory and quality systems and report any observations or critical situations identified to proactively ensure compliance. · Authorize product or device placement on the market after verifying conformity with specifications approved in the sanitary registration. · Ensure products are marketed exclusively to pharmaceutical establishments, authorized commercial establishments, or end consumers, as applicable. · Supervise, comply with, and enforce Good Storage Practices (GSP) internally and through third-party distributors, in accordance with current regulations. · Manage official manufacturer documentation and prepare technical files for Sanitary Registration. Ensure approval and validity to maintain an updated database of sanitary registrations. · Review technical files and update them in accordance with the sanitary registration and current regulations. · Maintain updated Technical Specifications for products registered with DIGEMID, for both Core and Non-Core products. · Address, as appropriate, complaints, claims, and product returns from users, and report to DIGEMID as required, in compliance with Pharmacovigilance and Technovigilance requirements. · Identify the need to update technical information related to sanitary registration. · Monitor that the quality assurance system across receipt, storage, distribution, and transportation stages ensures product preservation, stability, and quality. · Strictly monitor supplier compliance with specifications and requirements for sanitary registration of imported products, related to sales commercial activities. · Verify availability of documents and information for updating, registering, and re-registering medical device sanitary registrations; verify the status of regulatory procedures before the authority – DIGEMID. · Monitor compliance with Good Storage Practices (GSP) to maintain warehouse certification with DIGEMID. · Verify whether sanitary registrations include trade barriers disrupting the supply chain. · Verify that no contaminated, adulterated, counterfeit, expired, poorly preserved, or otherwise non-compliant products or devices are available for sale. · Analyze observations made by DIGEMID in the Technical File (e.g., registration, re-registration, updates, changes to QUIMICA EUROPEA product sanitary registrations). · Monitor, evaluate, and follow up on contracted services. · Within their scope of responsibility, monitor, evaluate, and oversee the operation of ISO management systems and Risk Management systems, per company guidelines. Competencies: * Planning * Commitment * Adaptability to change * Teamwork * Results orientation * Analytical thinking What does Zmart Works offer you? * Formal employment under the General Regime with benefits * Competitive salaries * Training and development opportunities * Mandatory Life Insurance If you are interested in this exciting opportunity and meet the above requirements, we would love to meet you. Please send your updated CV highlighting your experience. Send your CV with the subject line: Regulatory Affairs Assistant to administracion@zmartworks.com.pe and indicate your salary expectations. Position type: Full-time Salary: S/.1,800.00 - S/.2,000.00 per month Work location: On-site