Regulatory Affairs Specialist III

Regulatory Affairs Specialist III – Maplewood, MN (Hybrid)

Contract Duration: 18 months (possible extension).
Pay Rate Range: $45.00/hr – $55.00/hr on W2.
Work Authorization: Only U.S. Citizen or Green Card holder.

VARITE is an American‑headquartered life science and clinical research company and a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services. VARITE is an award‑winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies, leveraging its global experience and expertise in comprehensive scientific, engineering, technical, and non‑technical staff augmentation and talent acquisition services.

• Develop and execute global regulatory strategies that support new product commercialization and lifecycle management.
• Interpret emerging global regulations and communicate regulatory impacts to business stakeholders.
• Provide regulatory guidance throughout product development, change management, and product discontinuation activities.
• Ensure compliance with applicable global chemical, environmental, product safety, and industry‑specific regulations.
• Support regulatory submissions, product registrations, declarations of conformity, and compliance documentation where applicable.

• Lead product stewardship activities throughout the entire product lifecycle.
• Conduct product hazard, exposure, and risk assessments.
• Evaluate product composition for regulatory compliance and sustainability objectives.
• Partner with R&D and Product Management to identify regulatory risks early during product development.
• Develop mitigation strategies that balance regulatory compliance, customer expectations, and business objectives.
• Support responsible chemical management and sustainable product design initiatives.

• Provide expertise in applicable regulations including, but not limited to:
• TSCA
• REACH and UK REACH
• GHS and CLP
• RoHS
• Proposition 65
• PFAS regulations
• Food Contact regulations
• Drinking Water regulations
• Biocide regulations
• Chemical inventory requirements
• Hazard Communication standards
• FDA and USP requirements, where applicable

• Participate as the Regulatory Affairs and Product Stewardship representative on global product development teams.
• Support Stage Gate and design review processes.
• Review product claims, labels, instructions for use, technical literature, and marketing materials.
• Ensure regulatory requirements are incorporated into commercialization activities.
• Evaluate product changes for regulatory impact and coordinate required actions before implementation.

• Partner closely with Research & Development, Quality, Manufacturing, Operations, Environmental Health & Safety, Supply Chain, Procurement, Marketing, Sales, Legal, and Global Regulatory Affairs to ensure regulatory compliance while supporting business objectives and operational excellence.

• Respond to customer regulatory inquiries.
• Prepare compliance letters, declarations, certificates, and technical documentation.
• Support customer audits and regulatory assessments.
• Review customer questionnaires regarding product compliance and chemical content.
• Partner with Commercial teams to resolve customer regulatory concerns.

• Monitor emerging global regulations affecting Client's products and markets.
• Assess business impact and develop implementation strategies.
• Communicate regulatory changes to leadership and cross‑functional teams.
• Participate in industry associations and professional organizations to maintain current regulatory knowledge.

• Support Quality Management Systems including ISO 9001 and ISO 13485 where applicable.
• Participate in product risk assessments and Failure Mode and Effects Analysis (FMEA) activities.
• Contribute to continuous improvement initiatives that strengthen compliance and operational effectiveness.
• Support internal and external audits.

• Bachelor's degree in Chemistry,…