Regulatory Compliance Engineer II

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, analytical instrumentation, or other highly regulated industries preferred.
• Working knowledge of global product compliance and regulatory requirements such as EMC, PED, RoHS, REACH, PFAS, Cal Prop 65, Low Voltage Directive, Machine Directive, or similar standards.
• Experience interpreting technical regulations, customer requirements, and industry standards and translating them into business processes and compliance actions.
• Familiarity with 21 CFR Part 11, Annex 11, USP, EP, EDQM, JP, or comparable pharmaceutical and life sciences standards preferred.
• Experience coordinating external testing, certification, validation, or regulatory assessment activities is highly desirable.
• 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.

1. 1Understand 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.
2. 2Maintain the latest versions and subscriptions of standards applicable to products, services (USP, EP, EDQM, JP, among others), and systems implemented within the company, ensuring the organization remains aligned with evolving industry requirements.
3. 3Continuously build and maintain expertise in EMC, Low Voltage Directive, Machine Directive, Pressure Equipment Directive, and other emerging regulatory requirements that may impact Repligen's products, services, customers, and business operations.
4. 4Read and interpret regulatory requirements and customer technical specifications, assess applicability, and implement effective compliance processes that support business objectives and customer expectations.
5. 5Partner cross-functionally with QC, Engineering, EH&S, Support, Applications, Organizational Knowledge, and Sourcing teams to identify compliance gaps, provide recommendations, and drive effective solutions.
6. 6Apply and support corporate guidelines within the business unit, promoting consistency, accountability, and compliance across products and processes.
7. 7Maintain accurate, organized, and up-to-date compliance documentation for raw materials and products, including RoHS certifications, REACH declarations, Safety Data Sheets (SDS), and related regulatory records to support customer and business needs.
8. 8Support customer compliance requests by gathering technical information, providing documentation, and delivering timely, high-quality responses that strengthen customer confidence and trust.
9. 9Coordinate external testing, certification, and compliance activities with third-party organizations and laboratories, ensuring effective project execution, communication, and follow-through.
10. 10Monitor and support compliance efforts related to EMC, REACH, RoHS, PFAS, Pressure Equipment Directive (PED), and other applicable global regulations, proactively identifying risks and helping drive resolution.
11. 11Review, modify, and approve Quality Agreements and User Requirement Specifications (URS), ensuring alignment with regulatory requirements and company standards.
12. 12Work closely with Organizational Knowledge and other stakeholders to provide guidance aligned with corporate policies regarding trademarks, registered marks, and related compliance considerations.
13. 13Participate in product design and development activities, providing compliance guidance early in the product lifecycle and partnering with technical teams to support informed decision-making.
14. 14Help investigate compliance-related issues, support root cause analysis efforts, and collaborate with internal and external stakeholders to implement corrective actions when needed.
15. 15Develop, maintain, and continuously improve legal and regulatory requirements matrices for EH&S and product compliance programs, supporting long-term compliance readiness and operational excellence.