Regulatory Compliance Engineer II

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Comprehend legal obligations associated with Repligen's products and services, ensuring adherence to relevant industry regulations.

• Keep updated standards and subscriptions pertinent to products, services, and systems.

• Develop and sustain expertise in EMC, Low Voltage Directive, Machine Directive, Pressure Equipment Directive, and evolving regulatory requirements.

• Analyze regulatory obligations and customer technical specifications, implementing compliance processes accordingly.

• Collaborate with QC, Engineering, EH&S, Support, Applications, Organizational Knowledge, and Sourcing teams to pinpoint compliance gaps and formulate solutions.

• Enforce corporate guidelines within the business unit.

• Manage compliance documentation for raw materials and products, including RoHS certifications, REACH declarations, Safety Data Sheets, and regulatory records.

• Assist with customer compliance inquiries by collecting technical information and supplying necessary documentation.

• Oversee external testing, certification, and compliance initiatives with third-party organizations and laboratories.

• Supervise compliance efforts related to EMC, REACH, RoHS, PFAS, PED, and other international regulations.

• Review, amend, and approve Quality Agreements and User Requirement Specifications.

• Offer guidance on trademarks, registered marks, and associated compliance matters.

• Engage in product design and development, providing compliance guidance throughout the entire product lifecycle.

• Investigate compliance concerns, support root cause analysis, and execute corrective actions.

• Create and enhance matrices for legal and regulatory requirements pertaining to EH&S and product compliance programs.

⛳️ Requirements

• A Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, Chemistry, Physics, or a related technical field is required.

• At least 5 years of experience in regulatory compliance, product compliance, quality systems, or a related domain.

• Experience in life sciences, biopharmaceuticals, medical devices, diagnostics, analytical instrumentation, or other highly regulated sectors is preferred.

• Proficient understanding 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 in interpreting technical regulations, customer demands, and industry standards, 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 is preferred.

• Experience in coordinating external testing, certification, validation, or regulatory assessment activities is highly desirable.

• Strong analytical, problem-solving, and organizational capabilities with exceptional attention to detail.

• Proficient in working with ERP systems such as SAP and document management platforms, including SharePoint.

• Demonstrated ability to establish strong partnerships and effectively influence cross-functional stakeholders.

• Excellent written and verbal communication abilities.

• Proven track record of managing multiple priorities, adjusting to changing demands, and achieving results in a dynamic, growth-focused environment.

🏝️ Benefits

• Variable cash programs (bonus or commission).

• Equity opportunities for eligible roles.

• Paid time off.

• Health insurance coverage.

• Dental insurance options.

• Vision insurance plans.

• Retirement benefits.

• Flexible spending accounts.