Quality & Regulatory Specialist

Responsibilities

• Ensure regulatory compliance for medical device commercialization in Mexico and CAMCAR (Central America and Caribbean) in accordance with national and international regulations.
• Support the design, development, implementation, and maintenance of the Quality Management System (QMS) aligned with Getinge's global standards.
• Act as the Sanitary Responsible (Responsable Sanitario) to guarantee the quality of commercialized products.
• Manage the acquisition and maintenance of sanitary authorizations, licenses, registrations, and permits for medical devices and chemical products.
• Review and validate sanitary dossiers, including new registrations, extensions, and modifications.
• Authorize product labeling in compliance with internal procedures and applicable regulations.
• Support internal, external, and corporate audits by ensuring documentation availability and regulatory compliance.
• Manage product complaints and field actions, including reporting to health authorities and coordinating with manufacturing sites.
• Oversee technical vigilance (tecnovigilancia) processes and manage import permits.

Requirements

• Bachelor's degree in Biomedical Engineering.
• 3-5 years of experience in medical devices, pharmaceuticals, or diagnostic reagents.
• Proven experience with medical device registrations for Class I, II, and III devices.
• Strong knowledge of ISO 13485 and ISO 9001 standards.
• Proficiency in SAP and Microsoft Office tools.
• Advanced-intermediate English language skills.
• Documented experience in the import, distribution, and storage of medical devices.

Preferred Qualifications

• Experience with Good Manufacturing Practices (GMP) and Good Storage and Distribution Practices.
• Knowledge of Mexican sanitary regulations (LGS, RIS, and specific NOMs such as NOM-241-SSA1).

About the Company

MAQUET MEXICANA, S. DE R.L. DE C.V. is part of Getinge, a global leader in medical technology. Getinge provides hospitals and life science institutions with products and solutions aimed at improving clinical results and optimizing workflows across intensive care, cardiovascular procedures, operating rooms, and sterile reprocessing.