Regulatory Affairs Specialist III

Integrated Resources, Inc

Maplewood, MN

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JOB DETAILS

SALARY

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, 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, Team Player, Technical Leadership, Technical Marketing, Technical Writing, Toxicology, Writing Skills

LOCATION

Maplewood, MN

POSTED

1 day ago

Job Title: Regulatory Affairs Specialist III
Location: Maplewood, MN
Duration: 18 Months+
Pay: $50/hr. on W2

Description:

When you're part of ***, 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.

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 s upporting 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.

Comments:	Virtual interview, Monday thru Friday, 8:00-5:00, Can be flexible on work hours, Hybrid on site

About the Company

Integrated Resources, Inc

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