(OL-265) | SPEC 3, REGULATORY AFFAIRS

Sólo Para Miembros Registrados


Job summary embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Qualifications - Desired academic background: University Graduate in Engineering, Pharmacy, Biology, Medicine, and/or Biochemistry. - Desired work experience: 5-7 years in similar positions with experience in Health Product/Medical Device Industries. - Language level: Advanced English and native Spanish Responsibilities - Ensure compliance with local regulatory requirements/legislation and embecta Regulatory Affairs policies and procedures including special licenses/certifications. - Suggest and implement regulatory strategic and tactical plans for new products, product changes, and complex regulatory issues in alignment with company priorities. - Monitor the local regulatory environment and regulatory publications to anticipate strategies and communicate to the LATAM Sr Manager. - Develop and submit local regulatory applications for new registrations, product changes and renewals in a timely manner to ensure business growth and continuity. - Obtain and maintain records, registrations and notifications for products regulated by the Health Authorities and communicate to the function and business. - Support Adverse event reporting and vigilance follow up to regulatory agencies. - Support overseeing Field Action activities in the Andean and Southern cone region. - Support post-market surveillance reports according to regulatory requirements of the countries in the Andean and Southern cone region. - Support the generation of metrics, reports and basic presentations of the Regulatory Compliance processes to contribute to managerial decision making. - Support regulatory audits and inspections. - Support review and approval of local labeling, advertising and promotion to ensure compliance with local regulatory requirements. - Support the regulatory needs of external customers and/or tenders within the Andean and Southern cone region. Skills - Communication - Teamwork - Influencing others - Decision making - Planning, Coordination & Execution - Customer service approach Descripción del trabajo Lorem ipsum dolor sit amet , consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare. Donec lacinia nisi nec odio ultricies imperdiet. Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula. Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit , at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus. Obtén acceso completo Accede a todos los puestos de alto nivel y consigue el trabajo de tus sueños. Inscríbete ahora

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