Regulatory Compliance Engineer II

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.

Responsibilities

• 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

Requirements

• 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

Compensation: $85,000-$125,000 base