[Hiring] Regulatory Compliance Engineer II @RepliGen Corporation

Role 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.

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.
• Maintain the latest versions and subscriptions of standards applicable to products, services, and systems implemented within the company.
• Continuously build and maintain expertise in regulations, standards, and guidance applicable to single-use biopharmaceutical products.
• Read and interpret regulatory requirements and customer technical specifications, assess applicability, and implement effective compliance processes.
• Partner cross-functionally with various 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.
• Maintain accurate, organized, and up-to-date compliance documentation and data libraries.
• Support customer compliance requests by gathering technical information and regulatory documentation.
• Coordinate compliance activities with third-party compliance service providers and testing laboratories.
• Monitor and support compliance efforts related to various global regulations affecting single-use biopharmaceutical products.
• Review, modify, and approve Quality Agreements and User Requirement Specifications (URS).
• Work closely with Organizational Knowledge and other stakeholders to provide guidance on compliance considerations.
• Participate in product design and development activities, providing compliance guidance early in the product lifecycle.
• Help investigate compliance-related issues and collaborate with stakeholders to implement corrective actions.
• Develop and maintain regulatory compliance data repositories and documentation systems.
• Serve as a key resource for customer compliance inquiries.

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, or other highly regulated industries preferred.
• Working knowledge of global regulatory and product compliance requirements applicable to single-use biopharmaceutical products.
• Experience interpreting technical regulations, customer requirements, and industry standards.
• 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, 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 and drive results in a fast-paced environment.

Benefits

• Estimated base salary range: $85,000-$125,000.
• Eligibility to participate in variable cash programs (bonus or commission).
• Potential for equity as part of the compensation package.
• Paid time off.
• Health/dental/vision benefits.
• Retirement benefits.
• Flexible spending accounts.