Regulatory Affairs Professional
Machine translation — original language: Spanish.Show original
We are looking for a Regulatory Affairs Professional to comprehensively support and manage procedures before INVIMA, ensuring compliance with the sanitary regulations applicable to our products.
What will you do?
- Manage procedures for Sanitary Registrations, Marketing Authorizations, Sanitary Notifications, and Certificates of Non-Obligatoriness before INVIMA.
- Perform renewals, modifications, and authorizations.
- Request, review, and organize technical and legal documentation from suppliers.
- Prepare files, complete forms, and perform filings before INVIMA.
- Follow up on procedures until their approval or closure.
- Respond to orders and administrative acts within the established timeframes.
- Keep information updated regarding changes in the applicable regulations.
- Prepare reports and statements on the status of procedures.
- Provide support and advisory to the different areas of the company on regulatory affairs.
Requirements
Professional in Biomedical Engineering or related careers. Minimum of 2 years of experience. Knowledge of INVIMA regulations for medical devices and/or dermocosmetic products. Handling of technical and legal documentation for sanitary procedures. Proficiency in Microsoft Office. Excellent level of English. Excellent capacity for organization, analysis, communication, and attention to detail.
Location: Bogotá.
-Requirements-
Minimum education: University / Professional Career 2 years of experience
Knowledge:
- Adherence or compliance with standards
- Analytical capacity
- Coordination capacity
- Authorizations
- Marketing
- Documentation
- Reports
- Suppliers
- Sanitary
- Follow-up
- Biomedicine
Keywords:
experto, profesional, professional, expert