Regulatory Compliance Engineer II

Merck & Co.; Massachusetts; On-site; USD 85,000 - 125,000; Full time

Job summary

Repligen is seeking a Regulatory Compliance Engineer to support product compliance across Hardware, Automation, Chromatography, and Protein units. You will partner with engineering, quality, sourcing, and R&D to address complex compliance challenges and bring compliant products to market.

The role emphasizes integrity, customer focus, collaboration, and accountability, with responsibilities spanning standards management, regulatory interpretation, and documentation across global regimes.

Qualifications

• Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, Chemistry, Physics, or related field.
• Minimum 5 years of experience in regulatory compliance, product compliance, quality systems, or related field.
• Experience in life sciences, biopharma, medical devices, diagnostics, or analytical instrumentation preferred.
• Working knowledge of global product regulatory requirements (EMC, PED, RoHS, REACH, PFAS, etc.).
• Familiarity with 21 CFR Part 11, Annex 11, USP, EP, EDQM, JP or similar standards preferred.
• Experience coordinating external testing, certification, validation, or regulatory assessment activities.
• Strong analytical, problem-solving, and organizational skills; ability to manage multiple priorities.

Responsibilities

• Understand regulatory requirements and ensure compliance for products and services.
• Maintain up-to-date standards (USP, EP, EDQM, JP, etc.) for company systems.
• Develop expertise in EMC, LVD, Machinery, PED, and other regulations.
• Interpret regulatory requirements and customer specs to implement compliant processes.
• Collaborate with QC, Engineering, EH&S, Support, and Sourcing to close gaps.
• Prepare and maintain regulatory documentation (RoHS, REACH, SDS).
• Support customer compliance requests with timely, high-quality responses.
• Coordinate external testing and certifications with third-party labs.
• Monitor emissions for EMC, REACH, RoHS, PED, PFAS and related regs.
• Review and approve Quality Agreements and URS to meet regulatory standards.
• Provide guidance on trademarks and registered marks to ensure compliance.
• Assist in product design with regulatory input early in lifecycle.
• Investigate compliance issues and drive corrective actions.
• Develop and improve regulatory matrices for EH&S and product compliance.

Skills

Analytical thinking

Problem solving

Cross-functional collaboration

Communication skills

Attention to detail

Education

Bachelor's degree

Tools

SAP

SharePoint

Job description

Repligen is seeking a Regulatory Compliance Engineer to support product compliance activities across our Hardware, Automation, Chromatography, and Protein business units. In this highly collaborative role, you will help ensure our products meet global regulatory, environmental, and customer compliance requirements while partnering with engineering, quality, sourcing, and R&D teams to address complex compliance challenges. This is an excellent opportunity to contribute to innovative technologies, support a growing global organization, and play a key role in bringing compliant products to market.

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 (USP, EP, EDQM, JP, among others), and systems implemented within the company, ensuring the organization remains aligned with evolving industry requirements.
• Continuously 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.
• 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 QC, Engineering, EH&S, Support, Applications, Organizational Knowledge, 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 for raw materials and products, including RoHS certifications, REACH declarations, Safety Data Sheets (SDS), and related regulatory records to support customer and business needs.
• Support customer compliance requests by gathering technical information, providing documentation, and delivering timely, high-quality responses that strengthen customer confidence and trust.
• Coordinate external testing, certification, and compliance activities with third-party organizations and laboratories, ensuring effective project execution, communication, and follow-through.
• Monitor 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.
• 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, maintain, and continuously improve legal and regulatory requirements matrices for EH&S and product compliance programs, supporting long‑term compliance readiness and operational excellence.

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.

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.