Regulatory Affairs Specialist

Indotronix Avani Group; Saint Paul (MN); On-site; USD 62,000 - 69,000; Full time

Job summary

Indotronix Avani Group is seeking a Regulatory Affairs Specialist in Maplewood, MN for a 12-month contract. The role supports regulatory and product stewardship activities for a diverse life sciences product portfolio.

You will maintain product composition records, assist in regulatory submissions, and collaborate across functions to ensure compliance, safety, and sustainability throughout product lifecycles.

Qualifications

• Bachelor's degree in Chemistry or related scientific discipline.
• 3-5 years of regulatory affairs or product stewardship experience.
• Experience handling structured product and composition data in enterprise systems.
• Strong written and verbal communication skills.
• Ability to work effectively in cross-functional teams.

Responsibilities

• Support product stewardship activities across lifecycle.
• Assist in regulatory guidance and change management.
• Maintain product composition records and related attributes.
• Coordinate documentation for regulatory submissions and compliance.
• Collaborate with Regulatory, R&D, Quality, Manufacturing and Supply Chain teams.

Skills

Regulatory Knowledge

Data Management

Cross-functional Collaboration

Education

Bachelor's degree in Chemistry or related field

Tools

Regulatory Submissions Tools

Job description

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 organizations
• Strong relationship-building skills
• Effective communication with technical and non-technical audiences
• Continuous learning mindset
• Ability to balance compliance, innovation, and business objectives

Physical Requirements:

• Primarily office-based with occasional laboratory or manufacturing environment interaction. Occasional domestic and international travel (0-20%) may be required.