Regulatory Affairs Specialist Job Saint Paul area,Minnesota USA,Quality Assurance

Job Title:

Regulatory Affairs Specialist

Location:

Maplewood, MN 55119 Duration: 12 Months - Contract

Shift: M-F 8-5 Pay Rate: $45.00 - $50.00/hr w2 Position Summary

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
FDA and USP requirements, where applicable
Cross-Functional Collaboration

Partner closely with

Research & Development
Quality
Manufacturing
Operations
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
Strong scientific and technical aptitude
Excellent problem-solving and analytical skills
Customer-focused approach
Ability to collaborate effectively across global…