Global 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 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.