Regulatory Affairs - Sanitary Responsible

Job title: Regulatory Affairs - Sanitary Responsible

About the Role

Responsible for supporting compliance and monitoring regulatory requirements for the commercialization of the company’s products in Mexico and CAMCAR (Centroamérica y Caribe), in line with national and international regulations, as well as the regulatory requirements of MAQUET Mexicana (Getinge Mexico). Supports the design, development, implementation, administration and maintenance of the Quality Management System at MAQUET Mexicana (Getinge Mexico), aligned with national/international health regulations and Getinge's global QMS. Serves as the Sanitary Responsible to ensure the quality of products marketed by Maquet Mexicana (Getinge Mexico).

What You'll Do

• Contribute to obtaining and maintaining Sanitary Authorizations and Permits for medical devices, chemicals and other health inputs as required in Mexico and CAMCAR, to achieve commercial objectives and timely product launches.
• Ensure operational maintenance of authorizations: Licenses, Registrations, Certificates, Permits, Notices, etc., supporting the compilation of respective dossiers.
• Contribute to and assist in the management of the Maquet Mexicana (Getinge Mexico) QMS and its implementation with suppliers, 3PLs and distributors.
• Provide support for internal and external audits (regulatory/certification bodies) and corporate audits, ensuring documentation availability and compliance with current standards.
• Maintain an overall view of the technical, ethical and legal requirements applicable to the Sanitary Responsible role across processes where required.
• Review and validate sanitary dossiers according to current regulatory requirements, monitoring activities, ensuring compliance from submission to approval of new registrations, extensions, modifications, corrections and inquiries.
• Authorize product labeling in accordance with internal procedures and applicable regulations.
• Ensure proper control of regulatory documentation, as well as quality-related documentation, for traceability and compliance with regulatory and quality requirements.
• Support follow-up and compliance plans for registration conditions in technovigilance tasks such as blocking, withdrawal, elimination, release, among others, to guarantee maintenance and timely commercialization and risk management per internal policies.
• Manage import permits and stock-out deadlines, communicating required actions to be implemented.
• Support field actions communication and execution, reporting, tracking and closure with factories and Sanitary Authorities when required.
• Support handling of product complaints, reporting them to Sanitary Authorities and/or Getinge platforms as applicable.
• Manage permits, advertising notices and review of promotional materials in line with procedures and health regulation.
• Support compliance in the technovigilance process.
• Coordinate and support distribution of documents to the commercial area for tenders or marketing processes.
• Support regulatory area procedures and SGC improvements for Maquet Mexicana (Getinge Mexico) and Corporate SGC, and serve as back-up for the area head when applicable.
• Assist in required import processes by Trade/External Affairs to ensure proper product release in the appropriate system.
• Produce follow-up indicators for registrations, field actions, product releases.

What We're Looking For

• Biomedical Engineering degree with documented experience in import, distribution and storage of medical devices.
• 3-5 years of experience in similar roles and companies of similar size and complexity; desirable in medical devices, pharmaceuticals or diagnostic reagents sectors.
• Experience in regulatory submissions for Medical Devices Class I, II and III, and hazardous substances.
• Experience designing, developing, implementing, administering and maintaining ISO and GMP Quality Management Systems.
• Knowledge and interpretation of: Health Regulation, LGS, RIS, Regulation on Advertising of Health Inputs, NOM-137-SSA1, NOM-240-SSA1, NOM-241-SSA1, GMP, GDP; DOF agreements; Guidelines for Registration/Modifications of Medical Devices; ISO 13485, ISO 9001; English advanced-intermediate; PC literacy.