Regulatory Compliance Engineer II

🕒 September 15

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $85k - $125k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Repligen Corporation

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏭 Manufacturing

🏥 Healthcare

💼 Consulting

💰 $600M Post-IPO Debt - Repligen on 2023-12

Manufacturing • Healthcare • Consulting

<Repligen Corporation> Repligen Corporation is a life sciences company focused on bioprocessing technology leadership, providing scalable hardware, consumables and software for development and manufacture of biologic drugs and advanced therapies. Its portfolio includes upstream intensification systems (XCell ATF, KrosFlo TFDF), tangential flow filtration devices (KrosFlo, TangenX), chromatography systems and resins (KRM, OPUS, affinity and ion exchange resins), single-use fluid management and mixing solutions (ProConnex, MixOne, FlexBiosys products), dialysis devices, and real-time process analytics and control software (PATsmart, SoloVPE, FlowVPX). Repligen supports production of antibodies, proteins, viral vectors, mRNA, pDNA and other emerging modalities, and offers services, configurators and cGMP-ready solutions for biopharmaceutical manufacturers.

📋 Description

• 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, including USP, EP, EDQM, JP, ISO, and other relevant standards • Build and maintain expertise in regulations and guidance for single-use biopharmaceutical products, materials, and fluid management solutions • Interpret regulatory requirements and customer technical specifications, assess applicability, and implement compliance processes • Partner with Quality, Engineering, Support, Applications, Organizational Knowledge, Product Management, and Sourcing teams to identify compliance gaps and drive solutions • Apply corporate guidelines within the business unit • Maintain compliance documentation and data libraries for raw materials and finished products • Support customer compliance requests by gathering technical information, regulatory documentation, and compliance data • Coordinate compliance activities with third-party providers, testing laboratories, and certification organizations • Monitor compliance efforts related to REACH, RoHS, PFAS, California Proposition 65, USP, ISO, and other global regulations • Review, modify, and approve Quality Agreements and User Requirement Specifications • Provide guidance on trademarks, registered marks, and related compliance considerations • Participate in product design and development, providing compliance guidance throughout the product lifecycle • Investigate compliance-related issues, support root cause analysis, and implement corrective actions • Develop and maintain regulatory compliance data repositories and documentation systems • Serve as a resource for customer compliance inquiries and product onboarding, qualification, and ongoing support

🎯 Requirements

• 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, single-use technologies, bioprocessing consumables, polymers, analytical instrumentation, or other highly regulated industries preferred • Working knowledge of global regulatory and product compliance requirements applicable to single-use biopharmaceutical products, including REACH, RoHS, PFAS, California Proposition 65, USP standards, ISO standards, and related regulatory frameworks • Experience interpreting technical regulations, customer requirements, and industry standards and translating them into business processes and compliance actions • Experience with pharmaceutical and biocompatibility standards such as USP, ISO 10993, or similar standards strongly preferred • Experience coordinating external testing, certification, validation, or regulatory assessment activities highly desirable • Familiarity with ISO 11137 and related sterilization standards is a plus • Strong understanding of compliance documentation, material disclosures, supplier regulatory data, and customer compliance support activities • Experience maintaining regulatory documentation repositories, product compliance databases, or raw material compliance libraries preferred • 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

🏖️ Benefits

• Variable cash programs (bonus or commission) • Equity for eligible roles • Paid time off • Health, dental, and vision benefits • Retirement benefits • Flexible spending accounts

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