Regulatory Compliance Engineer II

RepliGen Corporation • Remote - Massachusetts, MA

2d • $85,000 - $125,000

About The Position

Repligen is seeking a Regulatory Compliance Engineer to support regulatory and product compliance activities for its Single-Use Fluid Management product portfolio. The role helps ensure materials, components, and finished products meet applicable regulatory, customer, and industry requirements. It partners with Quality, Engineering, Sourcing, Product Management, and external compliance providers to maintain regulatory documentation, respond to customer compliance requests, and keep products aligned with evolving biopharmaceutical industry standards.

The position requires interpreting regulations, customer specifications, and industry standards, then translating them into effective compliance processes and actions. It maintains compliance documentation and data repositories for raw materials and finished products; supports customer onboarding, qualification, and ongoing compliance inquiries; coordinates work with external service providers, laboratories, and certification organizations; and provides compliance guidance during product design and development. The role also supports investigations, root-cause analysis, corrective actions, and the review and approval of Quality Agreements and User Requirement Specifications. The successful candidate is expected to model Repligen’s Leadership Behaviors: Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results.

Requirements

• Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, Chemistry, Physics, or a related technical discipline.
• At least 5 years of experience in regulatory compliance, product compliance, quality systems, or a related field.
• Working knowledge of global regulatory and product compliance requirements for single-use biopharmaceutical products, including REACH, RoHS, PFAS, California Proposition 65, USP standards, ISO standards, and related frameworks.
• Experience interpreting technical regulations, customer requirements, and industry standards and translating them into business processes and compliance actions.
• Strong understanding of compliance documentation, material disclosures, supplier regulatory data, and customer compliance support activities.
• Strong analytical, problem-solving, and organizational skills, with exceptional attention to detail.
• Experience working with ERP systems such as SAP and document management platforms such as SharePoint.
• Ability to build strong partnerships and influence cross-functional stakeholders.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities, adapt to changing requirements, and drive results in a fast-paced, growth-oriented environment.

Nice To Haves

• Experience in life sciences, biopharmaceuticals, medical devices, diagnostics, single-use technologies, bioprocessing consumables, polymers, analytical instrumentation, or another highly regulated industry.
• Experience with pharmaceutical and biocompatibility standards such as USP <87>, USP <88>, USP <661>, USP <665>, ISO 10993, or similar standards.
• Experience coordinating external testing, certification, validation, or regulatory assessment activities.
• Familiarity with ISO 11137 and related sterilization standards.
• Experience maintaining regulatory documentation repositories, product compliance databases, or raw material compliance libraries.

Responsibilities

• Understand legal requirements related to Repligen products and services and ensure compliance with applicable industry regulations, serving as a resource on regulatory and product compliance matters.
• Maintain current versions and subscriptions of applicable standards, including USP, EP, EDQM, JP, ISO, and other relevant industry standards.
• 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, and California Proposition 65.
• Interpret regulatory requirements and customer technical specifications, assess their applicability, and implement compliance processes.
• Partner with Quality, Engineering, Support, Applications, Organizational Knowledge, Product Management, and Sourcing to identify compliance gaps, recommend solutions, and drive follow-through.
• Apply corporate guidelines within the business unit and promote consistency, accountability, and compliance across products and processes.
• Maintain accurate, organized, current compliance documentation and data libraries for raw materials and finished products, including REACH declarations, RoHS certifications, Safety Data Sheets, material disclosures, regulatory assessments, and related records.
• Respond to customer compliance requests by gathering technical information, regulatory documentation, and compliance data and providing timely, high-quality responses.
• Coordinate compliance activities with third-party compliance providers, testing laboratories, and certification organizations, including 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.
• Review, modify, and approve Quality Agreements and User Requirement Specifications (URS) for alignment with regulatory requirements and company standards.
• Work with Organizational Knowledge and other stakeholders to provide guidance on corporate policies concerning trademarks, registered marks, and related compliance considerations.
• Participate in product design and development, providing early compliance guidance and supporting informed decisions with technical teams.
• Help investigate compliance-related issues, support root-cause analysis, and collaborate with stakeholders to implement corrective actions.
• Develop and maintain regulatory compliance data repositories and documentation systems supporting customer requests, product stewardship, supplier data management, and long-term compliance readiness.
• Gather, maintain, and communicate regulatory, material, and product compliance information for customer onboarding, qualification, and ongoing support.

Benefits

• Paid time off
• Health insurance
• Dental insurance
• Vision insurance
• Retirement benefits
• Flexible spending accounts
• Eligible employees may participate in a variable cash program (bonus or commission).
• Eligible roles may receive equity as part of the compensation package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level