Regulatory Affairs

🕒 Setembro 18

🏄 California – Remoto

🏄 California – Remote

💵 $104.774 - $163.710 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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Agilent Technologies

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1999

🍽️ Alimentos e Bebidas

🏥 Saúde

💼 Consultoria

💰 $500.000.000 Post-IPO Debt em 2019-09

Food & Beverage • Healthcare • Consulting

A Agilent Technologies é líder global no campo de instrumentos analíticos e de laboratório. A empresa oferece um portfólio diversificado de produtos e soluções, incluindo cromatografia gasosa e líquida, espectrometria de massas, suprimentos de laboratório, além de software e soluções de informática. A Agilent atende a diversos setores, como o biofarmacêutico, testes de alimentos e bebidas, diagnóstico clínico e análises ambientais. Além disso, a Agilent oferece serviços abrangentes para gestão de laboratórios, manutenção e reparo de instrumentos. A empresa tem forte foco em avançar a ciência por meio de soluções sustentáveis e em apoiar genômica, patologia e pesquisa em câncer com tecnologias avançadas.

Descrição

• Ensure global product compliance and adherence to applicable regulatory requirements • Support regulatory submissions for product marketing in international markets • Provide regulatory input throughout product development from design and development through commercialization • Monitor evolving global regulations and assess their impact on company operations • Maintain regulatory documentation and support post-market compliance • Prepare, coordinate, and submit regulatory documentation and product registrations for the U.S., EU, Canada, LATAM, Asia-Pacific, Middle East, and MDSAP-participating countries • Compile, review, and maintain technical files, GSPRs, and CERs • Partner with R&D, Quality, and Commercial teams on product development, design control, labeling, and change control • Collaborate with Quality Systems on cGMP, GMP/QSR, ISO 13485, and MDSAP compliance • Perform product risk assessments and support complaint and non-conformance investigations • Manage recalls, MDR, advisory notices, and post-market regulatory reporting • Provide guidance on submission planning, global compliance strategies, risk classification, and literature research • Research and interpret global regulations and recommend compliance strategies • Manage product registration, listing, licensing, and business-license renewals • Develop regulatory SOPs, guidelines, templates, and training content; deliver compliance training • Review and approve labeling, IFUs, user manuals, SDSs, and promotional content • Monitor complaint-handling systems and support CAPA management • Track regulatory changes and perform gap analyses • Generate import/export documentation and facilitate customs clearance • Lead or support PMS activities, including complaint trend analysis, vigilance reporting, and PMS documentation under IVDR • Develop and execute PMPF plans and integrate performance data into CERs and risk management • Support internal and external audits and inspections; coordinate responses to findings • Assess regulatory impacts of product and process changes and support change control • Coordinate with external regulatory consultants or local agents and support regulatory project budgeting and planning • Support R&D from concept and feasibility through design, verification/validation, and commercialization • Provide ongoing regulatory support for marketed products, post-market modifications, and lifecycle management

🎯 Requisitos

• Practical experience in the IVD field, with a solid understanding of regulatory requirements • Knowledge of compliance requirements related to IVD Regulation (EU) 2017/746, NMPA, MFDS, AMDD, and other relevant markets • Familiarity with ISO 13485:2016, ISO 14971:2019, and MDSAP • Strong analytical and problem-solving skills • Effective interpersonal and cross-functional collaboration skills • Strong organizational skills, attention to detail, and ability to manage multiple priorities and deadlines with some guidance • Clear oral and written communication skills • Experience with eQMS platforms such as MasterControl, AssurX, or Veeva Vault QMS • Bachelor’s degree or equivalent experience • Minimum of three years of experience in the regulated medical device, IVD, or a related industry • Strong knowledge of international submissions across LATAM, the EU, Asia, and MDSAP countries • Experience with antibody-based diagnostics is strongly preferred • Excellent leadership, communication, and project management skills • Familiarity with MasterControl, Veeva Vault, or AssurX is highly desirable • Primarily local travel during the business day, with some out-of-area and overnight travel expected • Ability to work in the United States, based on the posting location

🏖️ Benefícios

• Eligibility for bonus • Stock • Benefits • Option to work remotely • Less than 20% travel required