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 regulatory compliance data repositories and documentation systems to support customer requests, product stewardship activities, supplier data management, and long-term compliance readiness.
- Serve as a key resource for customer compliance inquiries by gathering, maintaining, and communicating regulatory, material, and product compliance information required for customer onboarding, qualification, and ongoing support.
Education & Qualifications
- 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, single-use technologies, bioprocessing consumables, polymers, analytical instrumentation, or other highly regulated industries preferred.
- Working knowledge of global regulatory and product compliance requirements applicable to single-use biopharmaceutical products, including REACH, RoHS, PFAS, California Proposition 65, USP standards, ISO standards, and related regulatory frameworks.
- Experience interpreting technical regulations, customer requirements, and industry standards and translating them into business processes and compliance actions.
- Experience with pharmaceutical and biocompatibility standards such as USP <87>, USP <88>, USP <661>, USP <665>, ISO 10993, or similar standards is strongly preferred.
- Experience coordinating external testing, certification, validation, or regulatory assessment activities is highly desirable.
- Familiarity with ISO 11137 and related sterilization standards is a plus.
- Strong understanding of compliance documentation, material disclosures, supplier regulatory data, and customer compliance support activities.
- Experience maintaining regulatory documentation repositories, product compliance databases, or raw material compliance libraries preferred.
- 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.
Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $85,000-$125,000. Compensation decisions are dependent on several factors including, but not limited to an individual's ,qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.
