Global Regulatory Compliance Engineer — Bioprocessing

Repligen Corp; Massachusetts; Hybrid; USD 85,000 - 125,000; Full time

Benefits offered by this job

Health, dental, vision insurance

Retirement benefits

Flexible spending accounts

Bonus or commission program

Job summary

Repligen Corp. seeks 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 regulatory challenges and ensure products meet global requirements.

The role requires 5+ years in regulatory compliance, familiarity with EMC, RoHS, REACH, PED, and 21 CFR 11, with strong analytical and communication skills for cross-functional engagement.

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.

Responsibilities

• Understand legal requirements related to Repligen's products and services and ensure compliance with applicable industry regulations.
• Maintain the latest versions and subscriptions of standards applicable to products, services, and systems.
• Continuously build and maintain expertise in EMC, Low Voltage Directive, Machine Directive, PED, and other emerging regulatory requirements.
• Read and interpret regulatory requirements and customer technical specifications, assess applicability, and implement compliance processes.
• Partner cross-functionally with QC, Engineering, EH&S, Support, Applications, Organizational Knowledge, and Sourcing teams to identify compliance gaps and drive solutions.
• Apply and support corporate guidelines within the business unit, promoting consistency and compliance across products and processes.
• Maintain accurate compliance documentation for raw materials and products (RoHS, REACH, SDS).
• Support customer compliance requests by gathering technical information and delivering timely responses.
• Coordinate external testing, certification, and compliance activities with third-party organizations.
• Monitor and support compliance efforts related to EMC, REACH, RoHS, PFAS, PED, and other global regulations.
• Review, modify, and approve Quality Agreements and URS per regulatory requirements.
• Provide guidance on trademarks and related compliance considerations.
• Participate in product design to provide compliance guidance early in development.
• Investigate compliance issues and drive corrective actions when needed.
• Develop and improve regulatory matrices for EH&S and product compliance programs.

Skills

Regulatory compliance

Cross-functional collaboration

Analytical skills

Communication skills

Documentation management

Education

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

Tools

SAP

SharePoint

Job description

Repligen Corp. seeks 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 regulatory challenges and ensure products meet global requirements.

The role requires 5+ years in regulatory compliance, familiarity with EMC, RoHS, REACH, PED, and 21 CFR 11, with strong analytical and communication skills for cross-functional engagement.