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Biomedical Regulatory Affairs Leader 1626156928.47
COP 2,500,000/year
Indeed
Full-time
Onsite
No experience limit
No degree limit
Domicilio, Laureles - Estadio, Laureles, Medellín, Antioquia, Colombia
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Description

**Company Description:** The Employment Service operated by Comfama is the platform that connects individuals with companies offering job opportunities and seeking talent to contribute to their growth and consolidation. Job openings published by the Comfama Employment Service correspond to employment opportunities offered by companies in various sectors, located in Medellín and Antioquia. If you are interested in reviewing vacancies to connect professionally with Comfama, we recommend visiting our website www.comfama.com, option "Work with Us". **Job Functions:** AMBITO requests, for its team, personnel with a minimum of one year of experience to fill the position of Biomedical Regulatory Affairs Professional. **Academic Requirements:** Professional degree in Biomedical Engineering, Bioengineering, or related fields. **Specific Responsibilities:** * Perform regulatory management of client projects, ensuring regulatory compliance in Colombia (specifically medical devices) and providing specialized consultancy. * Obtain and maintain Sanitary Registrations and Marketing Permits before INVIMA. * Ensure proper application of ISO 13485:2016 standards in operations and advisory services. * Implement and audit regulatory processes. * Provide technical\-regulatory support to clients. **Knowledge:** * Solid knowledge of Colombian regulations (Decrees, Resolutions) for medical devices. * Knowledge of ISO 13485:2016 standard. * Advanced proficiency in INVIMA procedures and platforms. * INVIMA management. * Consulting. * Implementation and auditing. **Salary:** $2\.500\.000 \+ statutory benefits. **Working Hours:** Monday to Friday from 8:00 a.m. to 5:00 p.m. **Contract Type:** Permanent. **Work Location:** Medellín. **Requirements:** Minimum one year of experience **Offer Conditions:** **Net Monthly Salary:** 2500000

Source:  indeed View original post
Valentina Rodríguez
Indeed · HR

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