Regulatory Affairs Specialist

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

Job summary

Indotronix Avani Group in Maplewood, MN seeks a Regulatory Affairs & Product Stewardship Associate to support global regulatory compliance, product stewardship, and data management for life sciences products.

You will collaborate with Regulatory Affairs, Product Stewardship, R&D, Quality, EHS, Manufacturing, and Supply Chain teams to ensure lifecycle compliance and respond to customer inquiries.

Qualifications

• Bachelor’s degree in a related scientific field.
• 3–5 years in Regulatory Affairs, Product Stewardship, or related function.
• Experience managing structured data in enterprise systems.
• Strong analytical, organizational, communication, and PM 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

Product stewardship

Data management

Analytical skills

Project management

Quality systems

Education

Bachelor's degree in related scientific field

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.