Buscamos un analista de asuntos regulatorios estamos buscando a una persona con experiencia en la industria de alimentos, que se encargue de garantizar el cumplimiento normativo en los procesos de desarrollo, rotulado, producción y comercialización de alimentos, conforme a la normativa nacional vigente. la persona seleccionada será el enlace entre nuestra empresa y las entidades regulatorias, asegurando la correcta gestión de trámites y registros sanitarios. responsabilidades - asegurar el cumplimiento de la normatividad sanitaria aplicable a productos alimenticios. - realizar trámites ante entidades regulatorias, especialmente relacionados con registros sanitarios, renovaciones, actualizaciones, notificaciones sanitarias, entre otros. - verificar y validar el rotulado nutricional de productos conforme a la legislación vigente. - mantener actualizada la base documental con normas, leyes, resoluciones y requisitos aplicables al portafolio de productos. - acompañar procesos de desarrollo de nuevos productos, asegurando cumplimiento regulatorio desde la formulación hasta la comercialización. - brindar soporte técnico y regulatorio a las áreas de calidad, producción, compras y desarrollo. requisitos - profesional en ingeniería de alimentos, ingeniería química, ingeniería industrial, microbiología industrial o carreras afines. - mínimo 2 años de experiencia en cargos similares dentro de la industria de alimentos. - experiencia comprobada en trámites ante entidades regulatorias, obtención de registros sanitarios y revisión de etiquetado nutricional. beneficios - vinculaci...
Regulatory affairs specialist this role is responsible for supporting the regulatory team with various tasks, including preparation and submission of regulatory filings. the successful candidate will have a strong understanding of medical devices and their use, as well as an intermediate understanding of the regulatory submission process in different regions. key responsibilities: - preparation, assembly, storage, tracking, and retrieval of information pertinent to the regulatory processes - author and publish electronic submissions for product registrations, renewals, and registration changes - maintains registration databases, product registration records, key performance indicators current, and communicates approved registrations - executes registration processes in assigned countries, working closely with business unit regulatory teams to request information and business partners to ensure registrations are submitted on time the ideal candidate will have a bachelor's degree in a life science or related field and at least 3-5 years of experience in regulatory affairs, engineering, quality, or a related field. a minimum of one year of experience in the orthopedic or medical device industry is preferred. benefits: - up to 10% travel expectation - a competitive total rewards package - development opportunities and robust employee resource groups (ergs) - a flexible working environment and wellness incentives - a culture of recognition and performance awards requirements: - bachelor's degree in life sciences or related field - at least 3-5 years of experience in regu...
Job title: quality assurance and regulatory affairs specialist \ the quality assurance and regulatory affairs specialist will be responsible for supporting local quality and regulatory strategies, including local qms and regulatory compliance in colombia. this position requires in-depth and broad knowledge of colombian regulation applicable to medical devices, critical thinking, and collaboration skills. \ this role involves implementing the local quality management system in colombia, ensuring that local regulatory requirements and global align policies that impact the quality system are appropriately addressed by relevant qms procedures. additionally, it entails supporting qms activities such as management reviews, internal/suppliers audit, qms process training, and capa activities. \ another key responsibility is collaborating with cross-functional teams to ensure regulatory compliance across all operations. this includes maintaining regulatory affairs documentation to support compliance with applicable regulatory requirements. \ responsibilities include: \ \ - supporting the implementation of the local quality management system in colombia. \ - ensuring that local regulatory requirements and global align policies that impact the quality system are appropriately addressed by relevant qms procedures. \ - supporting qms activities such as management reviews, internal/suppliers audit, qms process training, and capa activities. \ - collaborating with cross-functional teams to ensure regulatory compliance across all operations. \ - maintaining regulatory affairs doc...
Job title: regulatory compliance leader job description: the regulatory compliance leader will be responsible for leading the development and implementation of regulatory compliance strategies across the european region. this role plays a critical part in ensuring regulatory compliance, managing risk, and enabling business growth by leveraging an evolving regulatory landscape. the incumbent will guide cross-functional teams on compliance matters related to raw materials, formulation, product claims, and finished goods specifications, while fostering strategic partnerships with external regulatory bodies and industry groups. key responsibilities: - build and manage a high-performing regulatory team, fostering capability development, cross-training, and succession planning. - lead all local and regional regulatory activities in alignment with company guidelines. - develop and execute long-range strategic direction for the regulatory function in support of business goals. - oversee regulatory compliance for raw materials, finished goods specifications, claims, labelling, and trade law across the region. - accountable for "right first time" documentation of finished goods specifications and raw material compliance. - customer-facing technical documentation (accurate, timely, and compliant with eu regulations) - proactively monitor regulatory trends, changes, and competitor intelligence in the eu region, communicating key insights and implications to global stakeholders. - develop sound regulatory strategies and risk mitigation plans aligned with product portfolios and inno...
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