Regulatory Affairs Specialist

Indotronix Avani Group; Maplewood (MN); On-site; USD 70,000 - 100,000; Full time

Job summary

Indotronix Avani Group is seeking a Regulatory Affairs & Product Stewardship Associate to support global regulatory compliance, product stewardship, and product composition data management for filtration, purification, bioprocessing, and life sciences products.

The role involves maintaining records, supporting hazard and risk assessments, and assisting with worldwide regulatory submissions and declarations. Collaboration with cross-functional teams is essential for lifecycle compliance.

Qualifications

• Bachelor's degree in a relevant scientific field.
• 3–5 years of experience in Regulatory Affairs, Product Stewardship, or related technical function.
• Experience managing structured product, material, chemical, or composition data in enterprise systems.
• Strong analytical, organizational, communication, and project management skills.

Responsibilities

• Maintain product composition, material, chemical, and substance records in enterprise systems.
• Support product hazard, exposure, and risk assessments.
• Assist with global regulatory compliance, submissions, product registrations, and declarations.
• Support compliance with TSCA, REACH, UK REACH, GHS, CLP, RoHS, PFAS, Proposition 65, and other applicable regulations.
• Prepare Safety Data Sheets (SDS), compliance letters, declarations, certificates, and technical documentation.
• Collaborate with Regulatory Affairs, Product Stewardship, R&D, Quality, EHS, Manufacturing, and Supply Chain teams.
• Respond to customer regulatory inquiries and support product lifecycle compliance.

Skills

Regulatory affairs experience

Product stewardship

Data management

Analytical skills

Organizational skills

Communication skills

Project management

Education

Bachelor's degree in a scientific field

Tools

Enterprise systems

Job description

Seeking a Regulatory Affairs & Product Stewardship Associate to support global regulatory compliance, product stewardship, and product composition data management for filtration, purification, bioprocessing, and life sciences products.

Key Responsibilities:

• Maintain product composition, material, chemical, and substance records in enterprise systems.
• Support product hazard, exposure, and risk assessments.
• Assist with global regulatory compliance, submissions, product registrations, and declarations.
• Support compliance with TSCA, REACH, UK REACH, GHS, CLP, RoHS, PFAS, Proposition 65, and other applicable regulations.
• Prepare Safety Data Sheets (SDS), compliance letters, declarations, certificates, and technical documentation.
• Collaborate with Regulatory Affairs, Product Stewardship, R&D, Quality, EHS, Manufacturing, and Supply Chain teams.
• Respond to customer regulatory inquiries and support product lifecycle compliance.

Minimum Qualifications:

• Bachelor's degree in Chemistry, Chemical Engineering, Biology, Toxicology, Environmental Science, Materials Science, or a related scientific field.
• 3–5 years of experience in Regulatory Affairs, Product Stewardship, Product Compliance, EHS, Quality, or a related technical function.
• Experience managing structured product, material, chemical, or composition data in enterprise systems.
• Strong analytical, organizational, communication, and project management skills.

Preferred: Knowledge of global chemical regulations, SDS preparation, product risk assessments, ISO 9001/13485, and experience with chemical, pharmaceutical, medical device, laboratory, or life sciences products.