Regulatory Compliance Engineer II

Repligen Corporation

. Understand legal requirements related to Repligen's products and services and ensure compliance with applicable industry regulations .

Posted 9/15/2026full-timeRemote • Massachusetts • United StatesMid-LevelSenior💰 $85,000 - $125,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance and product compliance within highly regulated industries, with a strong focus on interpreting and implementing global regulatory requirements. Proven ability to collaborate cross-functionally and manage compliance documentation effectively.

Highest-signal resume keywords

Regulatory ComplianceProduct ComplianceGlobal Regulatory RequirementsQuality SystemsAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsCompliance DocumentationTechnical Regulation InterpretationRoot Cause AnalysisCompliance Processes

Soft Skills

Problem-SolvingOrganizational SkillsCommunication SkillsInfluencing StakeholdersAttention to Detail

Tools & Technologies

ERP SystemsSAPDocument Management PlatformsSharePoint

Industry Keywords

Life SciencesBiopharmaceuticalMedical DeviceDiagnosticsAnalytical InstrumentationEMCRoHSREACHPFASLow Voltage Directive

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Understand legal requirements related to Repligen's products and services and ensure compliance with applicable industry regulations
Maintain current standards and subscriptions applicable to products, services, and systems
Build and maintain expertise in EMC, Low Voltage Directive, Machine Directive, Pressure Equipment Directive, and emerging regulatory requirements
Interpret regulatory requirements and customer technical specifications and implement compliance processes
Partner with QC, Engineering, EH&S, Support, Applications, Organizational Knowledge, and Sourcing teams to identify compliance gaps and drive solutions
Apply corporate guidelines within the business unit
Maintain compliance documentation for raw materials and products, including RoHS certifications, REACH declarations, Safety Data Sheets, and regulatory records
Support customer compliance requests by gathering technical information and providing documentation
Coordinate external testing, certification, and compliance activities with third-party organizations and laboratories
Monitor compliance efforts related to EMC, REACH, RoHS, PFAS, PED, and other global regulations
Review, modify, and approve Quality Agreements and User Requirement Specifications
Provide guidance regarding trademarks, registered marks, and related compliance considerations
Participate in product design and development, providing compliance guidance throughout the product lifecycle
Investigate compliance issues, support root cause analysis, and implement corrective actions
Develop and improve legal and regulatory requirements matrices for EH&S and product compliance programs

Requirements

What you’ll need

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 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
Demonstrated ability to manage multiple priorities, adapt to changing requirements, and drive results in a fast-paced, growth-oriented environment

Benefits

Comp & perks

Variable cash programs (bonus or commission)
Equity for eligible roles
Paid time off
Health insurance
Dental insurance
Vision insurance
Retirement benefits
Flexible spending accounts