What are the responsibilities and job description for the Regulatory Affairs Specialist position at Indotronix Avani Group?
Title: Regulatory Affairs Specialist
Duration: 12 Months
Work Arrangement: 100% Onsite
Interview: Virtual Group Interview
This role is on W2 NO C2C
Job Summary:
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.
Salary : $45 - $50