Regulatory Compliance Engineer II

🔥 14 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $85k - $125k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 • 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

🎯 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, 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

🏖️ Benefits

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