Regulatory Compliance Engineer II

🕒 Setembro 15

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $85.000 - $125.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 0%

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Repligen Corporation

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏭 Manufatura

🏥 Saúde

💼 Consultoria

💰 $600.000.000 Post-IPO Debt - Repligen em 2023-12

Manufacturing • Healthcare • Consulting

<Repligen Corporation> A Repligen Corporation é uma empresa de ciências da vida focada na liderança em tecnologia de bioprocessamento, fornecendo hardware, consumíveis e software escaláveis para o desenvolvimento e fabricação de medicamentos biológicos e terapias avançadas. Seu portfólio inclui sistemas de intensificação upstream (XCell ATF, KrosFlo TFDF), dispositivos de filtração de fluxo tangencial (KrosFlo, TangenX), sistemas e resinas de cromatografia (KRM, OPUS, resinas de afinidade e troca iônica), soluções de gestão e mistura de fluidos descartáveis (produtos ProConnex, MixOne, FlexBiosys), dispositivos de diálise e software de análise de processo e controle em tempo real (PATsmart, SoloVPE, FlowVPX). A Repligen apoia a produção de anticorpos, proteínas, vetores virais, mRNA, pDNA e outras modalidades emergentes, oferecendo serviços, configuradores e soluções prontas para cGMP para fabricantes biofarmacêuticos.

Descrição

• Understand legal requirements related to Repligen's products and services and ensure compliance with applicable industry regulations • Maintain current standards and subscriptions applicable to products, services, and systems • Build and maintain expertise in EMC, Low Voltage Directive, Machine Directive, Pressure Equipment Directive, and emerging regulatory requirements • Interpret regulatory requirements and customer technical specifications and implement compliance processes • Partner with QC, Engineering, EH&S, Support, Applications, Organizational Knowledge, and Sourcing teams to identify compliance gaps and drive solutions • Apply corporate guidelines within the business unit • Maintain compliance documentation for raw materials and products, including RoHS certifications, REACH declarations, Safety Data Sheets, and regulatory records • Support customer compliance requests by gathering technical information and providing documentation • Coordinate external testing, certification, and compliance activities with third-party organizations and laboratories • Monitor compliance efforts related to EMC, REACH, RoHS, PFAS, PED, and other global regulations • Review, modify, and approve Quality Agreements and User Requirement Specifications • Provide guidance regarding trademarks, registered marks, and related compliance considerations • Participate in product design and development, providing compliance guidance throughout the product lifecycle • Investigate compliance issues, support root cause analysis, and implement corrective actions • Develop and improve legal and regulatory requirements matrices for EH&S and product compliance programs

🎯 Requisitos

• Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, Chemistry, Physics, or a related technical discipline required • Minimum 5 years of experience in regulatory compliance, product compliance, quality systems, or a related field • Experience within life sciences, biopharmaceutical, medical device, diagnostics, analytical instrumentation, or other highly regulated industries preferred • Working knowledge of global product compliance and regulatory requirements such as EMC, PED, RoHS, REACH, PFAS, Cal Prop 65, Low Voltage Directive, Machine Directive, or similar standards • Experience interpreting technical regulations, customer requirements, and industry standards and translating them into business processes and compliance actions • Familiarity with 21 CFR Part 11, Annex 11, USP, EP, EDQM, JP, or comparable pharmaceutical and life sciences standards preferred • Experience coordinating external testing, certification, validation, or regulatory assessment activities highly desirable • Strong analytical, problem-solving, and organizational skills with exceptional attention to detail • Experience working with ERP systems such as SAP and document management platforms, including SharePoint • Proven ability to build strong partnerships and effectively influence cross-functional stakeholders • Excellent written and verbal communication skills • Demonstrated ability to manage multiple priorities, adapt to changing requirements, and drive results in a fast-paced, growth-oriented environment

🏖️ Benefícios

• Variable cash programs (bonus or commission) • Equity for eligible roles • Paid time off • Health insurance • Dental insurance • Vision insurance • Retirement benefits • Flexible spending accounts