Regulatory Compliance Engineer II - Biopharma Materials

Repligen Corporation; United States; Remote; USD 85,000 - 125,000; Full time

Benefits offered by this job

Health/dental/vision benefits

Paid time off

Retirement benefits

Flexible spending accounts

Job summary

Repligen Corporation seeks a Regulatory Compliance Engineer to support regulatory and product compliance activities for the Single-Use Fluid Management portfolio. You will work with Quality, Engineering, Sourcing, and Product Management to ensure materials, components, and finished products meet regulatory and industry requirements.

The role emphasizes collaboration, integrity, and accountability as you maintain compliance documentation, respond to customer requests, and support product

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.
• Working knowledge of global regulatory and product compliance requirements (REACH, RoHS, PFAS, California Prop 65, USP/ISO).
• Experience coordinating external testing, certification, validation, or regulatory assessment activities is desirable.

Responsibilities

• Understand and ensure regulatory compliance for products, services, and systems.
• Maintain regulatory standards subscriptions (USP, EP, EDQM, JP, ISO, etc.).
• Collaborate cross-functionally to identify compliance gaps and drive solutions.
• Review and approve Quality Agreements and URS to align with regulations.
• Support customer compliance requests with regulatory data and documentation.

Skills

Analytical thinking

Problem solving

Communication skills

Stakeholder influence

Education

Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, Chemistry, Physics, or related

5+ years regulatory compliance experience

Tools

SAP

SharePoint

Job description

Repligen Corporation seeks a Regulatory Compliance Engineer to support regulatory and product compliance activities for the Single-Use Fluid Management portfolio. You will work with Quality, Engineering, Sourcing, and Product Management to ensure materials, components, and finished products meet regulatory and industry requirements.

The role emphasizes collaboration, integrity, and accountability as you maintain compliance documentation, respond to customer requests, and support product