Regulatory Affairs Specialist

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Cook Group

SiteLinkedInTodas as Vagas

11 - 50 funcionários

⚕️ Seguro de Saúde

🧬 Biotecnologia

Healthcare Insurance • Biotechnology • Medical devices

Cook Group é um conjunto de empresas éticas e empreendedoras que existe para capacitar pessoas e comunidades a alcançarem seu pleno potencial. Enraizada em dispositivos médicos, a empresa também atua no setor de ciências da vida e se envolve em gestão de propriedades, resorts e negócios de serviços. Com sede em Indiana e presença mundial, a Cook Group valoriza integridade, qualidade, respeito e transparência, guiando seu trabalho e relacionamentos com funcionários, clientes e comunidades.

Descrição

• Communicate and interface directly with regulatory authorities to ensure product approvals are achieved in a timely manner, if needed. • Communicate Country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assist with the regulatory strategies. • Obtain and maintain product approval, and serve as a communication liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor. • Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions. • Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability. • Perform translation activities. • Provide support to currently marketed products as necessary including input on change requests, etc. • Collaborate with Regulatory Scientific Affairs on all high risk devices and new technologies. • Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data. • Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.

🎯 Requisitos

• Bachelor’s degree in a life science (preferably biology or chemistry), engineering, or other related field (such as law); • Proficient in reading, writing and speaking region specific language(s). • 3 years of prior relevant experience

🏖️ Benefícios

• Flexible work arrangements • Professional development opportunities