Regulatory Compliance Engineer II, Fluid Management at Repligen

Job description

Repligen is seeking a Regulatory Compliance Engineer to support regulatory and product compliance activities for our Single-Use Fluid Management product portfolio. In this highly collaborative role, you will help ensure materials, components, and finished products meet applicable regulatory, customer, and industry requirements. The position partners closely with Quality, Engineering, Sourcing, Product Management, and external compliance providers to maintain regulatory documentation, support customer compliance requests, and ensure ongoing alignment with evolving biopharmaceutical industry standards. This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work. Responsibilities Understand legal requirements related to Repligen's products and services and ensure compliance with applicable industry regulations while serving as a trusted resource for regulatory and product compliance matters. Maintain the latest versions and subscriptions of standards applicable to products, services, and systems implemented within the company, including USP, EP, EDQM, JP, ISO, and other relevant industry standards, ensuring the organization remains aligned with evolving regulatory and customer requirements. Continuously build and maintain expertise in regulations, standards, and guidance applicable to single-use biopharmaceutical products, materials, and fluid management solutions, including USP, ISO 10993, REACH, RoHS, PFAS, California Proposition 65, and other emerging requirements that may impact Repligen products and customers. Read and interpret regulatory requirements and customer technical specifications, assess applicability, and implement effective compliance processes that support business objectives and customer expectations. Partner cross-functionally with Quality, Engineering, Support, Applications, Organizational Knowledge, Product Management, and Sourcing teams to identify compliance gaps, provide recommendations, and drive effective solutions. Apply and support corporate guidelines within the business unit, promoting consistency, accountability, and compliance across products and processes. Maintain accurate, organized, and up-to-date compliance documentation and data libraries for raw materials and finished products, including REACH declarations, RoHS certifications, Safety Data Sheets (SDS), material disclosures, regulatory assessments, and related compliance records. Support customer compliance requests by gathering technical information, regulatory documentation, and compliance data, delivering timely and high-quality responses that strengthen customer confidence and support product adoption. Coordinate compliance activities with third-party compliance service providers, testing laboratories, and certification organizations, ensuring effective data collection, documentation management, project execution, and follow-through. Monitor and support compliance efforts related to REACH, RoHS, PFAS, California Proposition 65, USP standards, ISO standards, and other applicable global regulations affecting single-use biopharmaceutical products and raw materials. Review, modify, and approve Quality Agreements and User Requirement Specifications (URS), ensuring alignment with regulatory requirements and company standards. Work closely with Organizational Knowledge and other stakeholders to provide guidance aligned with corporate policies regarding trademarks, registered marks, and related compliance considerations. Participate in product design and development activities, providing compliance guidance early in the product lifecycle and partnering with technical teams to support informed decision-making. Help investigate compliance-related issues, support root cause analysis efforts, and collaborate with internal and external stakeholders to implement corrective actions when needed. Develop and maintain regulato