Regulatory Compliance Engineer II

Role: Regulatory Compliance Engineer supporting product compliance for Repligen's hardware, automation, chromatography, and protein units. Primary objectives include ensuring global regulatory, environmental, and customer compliance across products and services. Responsibilities encompass interpreting and implementing industry standards (e.g., EMC, RoHS, REACH, PED), maintaining compliance documentation, coordinating external testing and certification, and collaborating with cross-functional teams (engineering, quality, sourcing, R&D) to address compliance gaps. The role involves providing guidance during product development, supporting customer compliance requests, and monitoring evolving regulations. Qualifications: Bachelor's in Engineering, Life Sciences, Chemistry, or related field; 5+ years in regulatory compliance or quality systems, preferably within biopharma, medical devices, or diagnostics. Experience with global regulations such as EMC, PED, RoHS, REACH, and familiarity with standards like 21 CFR Part 11 is preferred. Skills: strong analytical, problem-solving, organizational, and communication abilities; proficient with ERP systems (SAP) and document management platforms. High-value specifics include experience in highly regulated industries, knowledge of pharmaceutical standards (USP, EP, EDQM, JP), and coordinating external testing activities. The work is largely collaborative and requires managing multiple priorities in a dynamic environment.