Global Regulatory Compliance Engineer

Repligen Corporation; Massachusetts; On-site; USD 85,000 - 125,000; Full time

Job summary

Repligen Corporation seeks a Regulatory Compliance Engineer to support product compliance across Hardware, Automation, Chromatography, and Protein units. You will ensure global regulatory, environmental, and customer requirements are met while partnering with engineering, quality, sourcing, and R&D teams to address complex compliance challenges.

This role emphasizes leadership behaviors and collaboration as you help bring compliant products to market and maintain accurate regulatory

Qualifications

• Bachelor's degree required 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, biopharmaceutical, medical device, diagnostics, analytical instrumentation, or other regulated industries preferred.
• Working knowledge of global product regulatory requirements (EMC, PED, RoHS, REACH, PFAS, Cal Prop 65, Low Voltage Directive, Machine Directive).
• Familiarity with 21 CFR Part 11, Annex 11, USP, EP, EDQM, JP or similar standards preferred.
• Experience coordinating external testing, certification, validation, or regulatory assessments is desirable.
• Strong analytical, problem-solving, organizational skills, and attention to detail.
• Experience with ERP systems such as SAP and SharePoint mentioned above.

Responsibilities

• Understand legal requirements related to Repligen's products and ensure compliance with industry regulations.
• Maintain current versions and subscriptions of applicable standards (USP, EP, EDQM, JP, etc.).
• Develop expertise in EMC, Low Voltage Directive, Machine Directive, PED, and other regulations.
• Read regulatory requirements and customer specs, assess applicability, and implement compliance processes.
• Partner with QC, Engineering, EH&S, Support, Applications, Organizational Knowledge, and Sourcing to address gaps.
• Apply and support corporate guidelines within the unit to promote consistency and compliance.
• Maintain up-to-date compliance documentation for raw materials and products (RoHS, REACH, SDS, etc.).
• Support customer compliance requests with technical info and timely responses.
• Coordinate external testing, certification, and regulatory activities with third parties.
• Monitor compliance efforts related to EMC, REACH, RoHS, PFAS, PED, and other regulations.
• Review, modify, and approve Quality Agreements and URS.
• Provide guidance on trademarks and related compliance considerations.
• Participate in product design to provide early compliance input.
• Investigate compliance-related issues and drive corrective actions when needed.
• Develop and improve regulatory requirement matrices for EH&S and product compliance programs.

Skills

Analytical skills

Problem-solving

Communication skills

Cross-functional collaboration

Prioritization / multitasking

Regulatory awareness

Education

Bachelor's degree in Engineering or related field

Tools

SAP

SharePoint

Job description

Repligen Corporation seeks a Regulatory Compliance Engineer to support product compliance across Hardware, Automation, Chromatography, and Protein units. You will ensure global regulatory, environmental, and customer requirements are met while partnering with engineering, quality, sourcing, and R&D teams to address complex compliance challenges.

This role emphasizes leadership behaviors and collaboration as you help bring compliant products to market and maintain accurate regulatory