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Business Professional - Regulatory Affairs Specialist
LanceSoft Inc
- 🇺🇸 United States
- On-site
- 15 hours ago
- $45 – $50 / hour
- Regulatory Compliance
- Change Management
15 hours ago
Not enough detail in this posting to match
Location: Maplewood, Minnesota 55119
Duration: 0-12+ Months
Shift: 8:00 AM – 5:00 PM
Pay: $45.00 - $50.00/ Hour
As a Regulatory Affairs & Product Stewardship Associate 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.
You will also play a key role in maintaining accurate, complete, and reliable product composition information used to support regulatory compliance, product stewardship, customer requirements, and product lifecycle management.
The role combines regulatory and product stewardship knowledge with strong data management discipline.
Key Responsibilities
Product Stewardship
• Support product stewardship activities throughout the entire product lifecycle
• Assist in conducting product hazard, exposure, and risk assessments
• Maintain product composition records, including material, substance, component, and related product attributes, in accordance with established business and regulatory requirements.
• Coordinate creation, update, review, approval, and retirement of composition records throughout the product lifecycle.
• Partner with Product Stewardship, Regulatory, R&D, Engineering, Quality, Operations, Supply Chain, and other functions to obtain and validate source information.
• Assist in developing mitigation strategies that balance regulatory compliance, customer expectations, and business objectives
• Support responsible chemical management and sustainable product design initiatives
Regulatory Strategy & Compliance
• Support regulatory guidance activities throughout product development, change management, and product discontinuation activities
• Assist in ensuring compliance with applicable global chemical, environmental, product safety, and industry-specific regulations
• Assist with regulatory submissions, product registrations, declarations of conformity, and compliance documentation where applicable
Global Regulatory Compliance
Develop knowledge and support compliance with applicable regulations including, but not limited to:
• TSCA
• REACH and UK REACH
• GHS and CLP
• RoHS
• Proposition 65
• PFAS regulations
• Food Contact regulations
• Biocide regulations
• Chemical inventory requirements
• Hazard Communication standards
• FDA and USP requirements, where applicable
Cross-Functional Collaboration
Partner closely with:
• Research & Development
• Quality
• Manufacturing
• Operations
• Environmental Health & Safety
• Supply Chain
• Procurement
• Marketing
• Legal to support regulatory compliance while supporting business objectives and operational excellence.
Customer & Commercial Support
• Assist in responding to customer regulatory inquiries
• Support preparation of compliance letters, declarations, certificates, and technical documentation
Minimum Qualifications
• Bachelor's degree in Chemistry, Chemical Engineering, Biology, Toxicology, Environmental Science, Materials Science, Life Sciences, Engineering, or another related scientific discipline
• 3-5 years of experience in Regulatory Affairs, Product Stewardship, Environmental Health & Safety, Product Compliance, Quality, or related technical functions (internships and co-op experience may be considered)
• Experience working with structured product, material, chemical, or composition data in enterprise systems.
• Demonstrated interest in regulatory compliance programs
• Ability to work effectively in cross-functional technical teams
• Excellent written and verbal communication skills
• Strong analytical, organizational, and project management skills
• Ability to manage multiple priorities within a fast-paced global environment
Preferred Qualifications
• Experience or coursework related to filtration, purification, laboratory, bioprocessing, diagnostics, medical device, pharmaceutical, or chemical products
• Basic knowledge of global chemical regulations including TSCA, REACH, GHS, CLP, RoHS, PFAS, Food Contact, and Hazard Communication requirements
• Exposure to product risk assessments and lifecycle evaluations
• Knowledge of ISO 9001, ISO 13485, and quality management systems
• Experience preparing Safety Data Sheets (SDS), regulatory declarations, and customer compliance documentation
Competencies
Successful candidates demonstrate:
• Strong scientific and technical aptitude
• Excellent problem-solving and analytical skills
• Customer-focused approach
• Ability to collaborate effectively across global organizations
• Strong relationship-building skills
• Effective communication with technical and non-technical audiences
• Continuous learning mindset
• Ability to balance compliance, innovation, and business objectives
Interview process - Virtual Group Interview
Physical Requirements
Primarily office-based with occasional laboratory or manufacturing environment interaction. Occasional domestic and international travel (0–20%) may be required.
Business Professional - Regulatory Affairs Specialist · LanceSoft Inc