Regulatory Affairs Specialist III

Regulatory Affairs Specialist III

VARITE is looking for qualified Regulatory Affairs Specialist III in Maplewood, MN.

An American-headquartered life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services.

Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.

Job Title:

Regulatory Affairs Specialist III

Location:

Maplewood, MN

Contract Duration: 18 months (Possible Extension)

Pay Rate Range: $45.00/hr. to $55.00/hr. on W2

Work Mode:
Hybrid

Work Authorization:
Only USC or GC

Here's What You'll Do

When you're part of Client, you'll do challenging work while collaborating with a team that values performance, quality, innovation, and continuous improvement. Our global organization enables our customers to make the world healthier, cleaner, and safer by delivering industry-leading technologies and solutions.

As a Regulatory Affairs & Product Stewardship Specialist within the Filtration & Separation business, you will support regulatory and product stewardship activities for a diverse portfolio of filtration, purification, bioprocessing, and life sciences products. This position plays a critical role in helping ensure products remain compliant, safe, and sustainable throughout their lifecycle while supporting business growth, innovation, and customer success.

Regulatory Strategy & Compliance:

• 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.

Product Stewardship:

• 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.

Global Regulatory Compliance:

• 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

New Product Introduction (NPI):

• 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.

Cross-Functional Collaboration:

Partner closely with:

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

Customer & Commercial Support:

• Respond to customer regulatory inquiries.
• Prepare…