Remote Regulatory Compliance Engineer II — Life Sciences

Repligen Corporation; Northern (KY); Hybrid; USD 85,000 - 125,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision insurance

Retirement benefits

Flexible spending accounts

Job summary

Repligen Corporation is seeking a Regulatory Compliance Engineer II to support global product compliance across hardware, automation, chromatography and protein units. You will partner with engineering, quality and R&D to ensure conformity with EMC, RoHS, REACH, PFAS and other standards throughout the product lifecycle.

The role demands strong documentation, stakeholder influence, and proactive risk management.

Qualifications

• Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, Chemistry, Physics, or related technical discipline.
• Minimum 5 years of experience in regulatory compliance or related field.
• Experience with global product compliance standards (EMC, RoHS, REACH, PFAS, PED).
• Familiarity with 21 CFR Part 11, Annex 11, USP/EP/EDQM/JP standards.

Responsibilities

• Understand legal requirements and ensure regulatory compliance for products and services.
• Maintain up-to-date standards and regulatory subscriptions (USP, EP, EDQM, JP, etc.).
• Develop expertise in EMC, LV Directive, PED and other directives affecting products.
• Interpret regulatory requirements and implement compliant processes aligned with business goals.
• Collaborate cross-functionally to identify gaps and drive solutions.
• Maintain regulatory documentation for materials and products (RoHS, REACH, SDS).
• Support customer compliance requests with timely, high-quality responses.
• Coordinate external testing, certification, and regulatory assessments.
• Monitor regulatory activities and advise on risk and mitigation actions.
• Review and align Quality Agreements and URS with regulatory expectations.
• Provide guidance on trademarks and compliance considerations within corporate policy.
• Participate in product design to embed compliance early in lifecycle.
• Investigate compliance issues and support corrective actions.
• Develop matrices for EH&S and product compliance programs.

Skills

Analytical thinking

Cross-functional collaboration

Communication skills

Regulatory interpretation

Education

Bachelor's degree (Engineering/Regulatory/Life Sciences)

Tools

SAP

SharePoint

Job description

Repligen Corporation is seeking a Regulatory Compliance Engineer II to support global product compliance across hardware, automation, chromatography and protein units. You will partner with engineering, quality and R&D to ensure conformity with EMC, RoHS, REACH, PFAS and other standards throughout the product lifecycle.

The role demands strong documentation, stakeholder influence, and proactive risk management.