Regulatory Affairs Manager

Description

Job Summary: We are seeking a Regulatory Affairs Specialist to ensure the validity and legality of our product catalog through sanitary registration management and regulatory compliance. Key Highlights: 1. Manages regulatory procedures before COFEPRIS and ensures regulatory compliance 2. Ensures regulatory continuity of the product portfolio 3. Opportunity for professional development and growth within a solid company **Do you have experience in regulatory affairs within the healthcare sector and are seeking an opportunity to grow within a solid and expanding company?** At **Corporativo Salazar**, we are looking for a **Regulatory Affairs Specialist**, responsible for ensuring the validity and legality of our product catalog through proper sanitary registration management and compliance with applicable Mexican regulations. You will be a key player in ensuring that our regulatory processes remain aligned with standards established by health authorities. **What will you do on a daily basis?** * **Operational Management:** Execute and supervise the full cycle of procedures before COFEPRIS (new registrations, renewals, and modifications). * **Regulatory Control:** Verify that labeling, packaging, and advertising comply with current NOMs. * **Platform Administration:** Manage submission and tracking of procedures in DIGIPRiS and VUCEM, ensuring accuracy and technical compliance. * **Documentary Archiving and Control:** Maintain updated databases, files, and technical dossiers for audits and regulatory reviews. * **Regulatory Monitoring:** Monitor expiration dates and ensure regulatory continuity of the product portfolio. * **Team Collaboration:** Coordinate with internal departments to guarantee regulatory compliance in processes and documentation. **What do you need to join our team?** * **Academic Qualification:** Completed bachelor’s degree with diploma in health-related fields (Chemistry and Pharmacy, Pharmacy, Biomedical Engineering, Biology, or related disciplines). * **Essential Experience:** 2–5 years of experience in regulatory affairs for medical devices. * **Technical Knowledge:** Demonstrable proficiency in NOM-241 and NOM-137. * **Platforms:** Proficiency in DIGIPRiS and VUCEM. * **Profile:** Organized, analytical individual with strong attention to detail and ability to work under strict deadlines. * **Skills:** Tracking, documentary control, and regulatory compliance. **What do we offer?** * **Attractive base salary** * **Direct hiring** * **Opportunity for professional development and growth** **Benefits:** * IMSS, INFONAVIT, year-end bonus, vacation time, and vacation premium * Employee discounts **Work Schedule:** Monday to Friday **Work Location:** Guadalajara, Jalisco Salary: Up to $18,000.00 per month Benefits: * Employee discount * Discounts and preferential pricing * Option for indefinite-term contract * Referral program * Company phone Workplace: On-site employment