Regulatory Affairs Specialist

LanceSoft Inc

Maplewood, MN

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JOB DETAILS

SALARY

$55–$55 Per Hour

SKILLS

Analysis Skills, Biology, Biotech and Pharmaceutical, Business Growth, Business Operations, Business Support, Business impact analysis (BIA), Change Management, Chemical Engineering, Chemistry, Communication Skills, Continuous Improvement, Cross-Functional, Customer Relations, Customer Support/Service, Datasheets, Documentation, Environmental Chemistry, Environmental Health, Environmental Sciences, External Audit, Failure Mode and Effects Analysis (FMEA), Hazardous Materials/Substances, ISO (International Organization for Standardization), ISO 9001, Internal Audit, Interpret Regulations, Leadership, Legal, Maintain Compliance, Manufacturing, Marketing, Material Science, Materials Management, Medical Diagnosis, Medical Equipment, Monitor Regulations, Multitasking, Network Connectivity, Operational Strategy, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product Design, Product Development, Product Lifecycle, Product Lifecycle Management, Product Management, Product Positioning, Product Programs, Product Reviews, Product Safety, Product Support, Product Testing, Product/Service Launch, Project/Program Management, Purchasing/Procurement, Quality Management, Reduction of Hazardous Substances (RoHS), Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Risk Analysis, Risk Management, Safety Compliance, Safety/Work Safety, Sales, Stewardship, Strategic Planning, Supply Chain, Sustainability, Technical Marketing, Technical Writing, Toxicology, Writing Skills

LOCATION

Maplewood, MN

POSTED

1 day ago

Shift: Monday thru Friday, 8:00-5:00, Can be flexible on work hours,
Duration: 15-18 Months
Pay range: $45.00 - $55.00 Hourly
Hybrid on site
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.

Key Responsibilities
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 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.
Regulatory Intelligence
• Monitor emerging global regulations affecting Client 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.
Quality & Risk Management
• 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.
________________________________________
Minimum Qualifications
• Bachelor's degree in Chemistry, Chemical Engineering, Biology, Toxicology, Environmental Science, Materials Science, Life Sciences, Engineering, or another related scientific discipline.
• Minimum five (5) years of experience in Regulatory Affairs, Product Stewardship, Environmental Health & Safety, Product Compliance, Quality, or related technical functions.
• Demonstrated experience supporting global regulatory compliance programs.
• Experience working 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 supporting filtration, purification, laboratory, bioprocessing, diagnostics, medical device, pharmaceutical, or chemical products.
• Knowledge of global chemical regulations including TSCA, REACH, GHS, CLP, RoHS, PFAS, Food Contact, and Hazard Communication requirements.
• Experience supporting New Product Introduction (NPI) and product lifecycle management.
• Experience performing 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.
• Regulatory Affairs Certification (RAC), Certified Hazardous Materials Manager (CHMM), or other applicable professional certifications.
________________________________________
Competencies
Successful candidates demonstrate:
• Strong scientific and technical judgment.
• Excellent problem-solving and risk assessment skills.
• Customer-focused decision making.
• Ability to influence without authority across global organizations.
• Strong collaboration and relationship-building skills.
• Effective communication with technical and non-technical audiences.
• Continuous improvement mindset.
• Ability to balance compliance, innovation, and business objectives.

Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:

Four options of medical Insurance
Dental and Vision Insurance
401k Contributions
Critical Illness Insurance
Voluntary Permanent Life Insurance
Accident Insurance
Other Employee Perks

About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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