Regulatory Affairs Chemist

Description

Position Summary: The Regulatory Affairs Chemist manages and maintains sanitary registrations with COFEPRIS to ensure regulatory compliance and marketability of products, preparing filings and responding to authorities. Key Highlights: 1. Manages and maintains sanitary registrations with COFEPRIS. 2. Ensures regulatory and legal compliance of products. 3. Conducts regulatory procedures and responds to authorities' requirements. A leading medical device manufacturing company is seeking: **Regulatory Affairs Chemist Position Purpose** To manage and maintain sanitary registrations with COFEPRIS, ensuring products comply with current legal and regulatory frameworks to guarantee their free marketability. **Key Responsibilities** * **Filing Management:** Preparation and submission of new registrations, renewals, and modifications. * **Regulatory Compliance:** Review of labeling, packaging, and instructions according to sanitary regulations. * **Regulatory Liaison:** Addressing preventive actions and technical requirements from authorities. * **Technical Dossier:** Compilation and safekeeping of scientific and legal documentation. * **Regulatory Surveillance:** Monitoring updates to the General Health Law and Official Standards. **Required Profile** * **Education:** Bachelor's degree in Pharmacy and Biochemistry (QFB), Food Engineering (QFI), or Chemistry. * **Experience:** 2 years in regulatory affairs (Medical Devices / Pharma). **Technical Competencies:** * Proficiency in **NOM-241-SSA1** and the General Health Law. * Experience using the **DIGIPRiS** platform. * Excellent spelling and technical writing skills. **Employment Offer** * **Location:** Chalco, State of Mexico. * **Schedule:** Monday to Saturday. * **Compensation:** Statutory benefits + food vouchers. * **Benefits:** Free transportation and punctuality/attendance bonuses. Salary: Starting at $15,000.00 MXN per month Workplace: On-site employment