Regulatory Specialist – Level 2

🕒 Agosto 15

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 22%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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EXALTA Group

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

🎖️ Defesa

Healthcare • Consulting • Defense

O Grupo EXALTA é uma OEM MedTech integrada que co-desenvolve, projeta e fabrica dispositivos médicos ortopédicos e adjacentes, desde o conceito até a liberação regulatória e lançamento no mercado. A empresa oferece desenvolvimento completo de dispositivos, suporte regulatório (510(k) e EU MDR), usinagem de precisão, forjamento, acabamento e vigilância pós-mercado em áreas como coluna, trauma, extremidades, reconstrução, além de tecnologias habilitadoras como robótica cirúrgica e navegação. A EXALTA destaca-se pela rapidez no lançamento ao mercado, escala global de manufatura com opções de nearshoring, infraestrutura de QMS validada e resiliência da cadeia de suprimentos para parceiros OEM.

Descrição

• Provide regulatory support to product development and business teams • Prepare regulatory opinion documents and coordinate labeling activities • Review and approve design control documentation, risk management reports, technical protocols/reports, clinical documentation, and other product-development outputs • Prepare, write, submit, and manage global regulatory applications, including MDSAP markets, the EU, and the UK • Maintain internal regulatory file documentation • Support distributors and business partners in securing and maintaining regulatory clearances • Track current projects and forecast future activity loads • Develop and maintain relationships with global regulatory agencies and business partners • Collaborate cross-functionally with research and development, operations, quality, microbiology, packaging, medical affairs, and clinical affairs • Assess product design, labeling, quality system, manufacturing, and material changes for regulatory impact • Author responses to proposed standards, directives, policies, and legislation • Develop, process, and maintain departmental procedures, work instructions, and forms; facilitate training • Support the design, development, review, and approval of product labels, advertising/promotional materials, product claims, and instructions for use • Monitor and assess changes to global regulations, directives, standards, and guidance requirements • Manage project teams to complete compliance activities • Support regulatory aspects of the quality system and product non-conformities • Lead assigned corrective and preventive action activities • Participate in internal audits and external audits

🎯 Requisitos

• Bachelor’s degree in a scientific or technical discipline, preferably regulatory, engineering, or biological science • Minimum 3 years of relevant experience • 5 or more years of relevant experience may substitute for the degree • RAC certification(s) a plus • Strong understanding of product development, design controls, and risk management • Strong understanding of medical terminology and medical-device and quality-system regulations and guidelines • Knowledge of FDA Quality Management System Regulation (QMSR), MDD 93/42/EEC, MDR 2017/745, and ISO 13485 • Computer proficiency and ability to learn new technology and tools quickly • Project management knowledge and ability to monitor project status and deliver accurate status reporting • Proficient written and verbal communication and presentation skills • High attention to detail, problem-solving, decision-making, organization, and time-management skills • Ability to work independently and cross-functionally • Ability to handle objects up to 20 lbs. occasionally • Ability to sit for 8 hours per day and stand for 1 hour per day • Ability to perform repetitive tasks/motions, with good manual dexterity and eye/hand/foot coordination • Ability to hear alarms, telephone, and normal speaking volume; clarity of vision • Ability to work in a manufacturing environment with potential exposure to listed hazards

🏖️ Benefícios

• Remote work • Personal protective equipment provided/required for applicable tasks, including scrubs, gloves, masks, safety glasses, and safety shoes