Regulatory Compliance Engineer II

Repligen · Remote

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RegulatoryRemoteFull-time$85k–$125kCompany career page

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Role summary

Repligen seeks a Regulatory Compliance Engineer to support product compliance across hardware, automation, chromatography, and protein business units. The role involves ensuring global regulatory adherence, maintaining standards knowledge, and partnering cross-functionally to address compliance challenges in a remote Massachusetts-based position.

What they're looking for

Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, Chemistry, Physics, or related technical discipline
Minimum 5 years regulatory compliance, product compliance, or quality systems experience
Working knowledge of EMC, PED, RoHS, REACH, PFAS, Low Voltage Directive, or Machine Directive
Experience interpreting technical regulations and translating them into business processes
Familiarity with 21 CFR Part 11, Annex 11, USP, EP, EDQM, JP, or pharmaceutical standards preferred
Experience coordinating external testing, certification, and regulatory assessment activities
Strong analytical, organizational skills with attention to detail and cross-functional influence ability

What you'll be doing

Understand and ensure compliance with applicable industry regulations for Repligen products and services
Maintain current versions of standards subscriptions and assess regulatory applicability to products and systems
Partner cross-functionally with QC, Engineering, EH&S, and Sourcing teams to identify and resolve compliance gaps
Maintain accurate compliance documentation including RoHS certifications, REACH declarations, and safety data sheets
Support customer compliance requests, coordinate external testing activities, and investigate compliance-related issues

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