Regulatory Affairs Specialist III

Indotronix International Corporation • Maplewood, MN

3d • Hybrid

About The Position

The Regulatory Affairs Specialist III will develop and execute global regulatory strategies that support new product commercialization and lifecycle management. This role involves interpreting emerging global regulations, communicating regulatory impacts to business stakeholders, and providing regulatory guidance throughout product development, change management, and product discontinuation activities. The specialist will ensure compliance with applicable global chemical, environmental, product safety, and industry-specific regulations, and support regulatory submissions, product registrations, declarations of conformity, and compliance documentation. Additionally, the role leads product stewardship activities throughout the entire product lifecycle, including conducting product hazard, exposure, and risk assessments, and evaluating product composition for regulatory compliance and sustainability objectives. The specialist will partner with R&D and Product Management to identify regulatory risks early during product development and develop mitigation strategies. This position requires expertise in various global regulations such as TSCA, REACH, GHS, CLP, RoHS, Proposition 65, PFAS, Food Contact, Drinking Water, Biocide regulations, chemical inventory requirements, Hazard Communication standards, and FDA/USP requirements where applicable. The role also involves participating as the Regulatory Affairs and Product Stewardship representative on global product development teams, supporting Stage Gate and design review processes, reviewing product claims, labels, instructions for use, technical literature, and marketing materials, and ensuring regulatory requirements are incorporated into commercialization activities. The specialist will evaluate product changes for regulatory impact and coordinate required actions before implementation. Cross-functional collaboration with R&D, Quality, Manufacturing, Operations, EHS, Supply Chain, Procurement, Marketing, Sales, Legal, and Global Regulatory Affairs is essential. Customer and commercial support includes responding to regulatory inquiries, preparing compliance documentation, supporting audits, and reviewing customer questionnaires. Regulatory intelligence involves monitoring emerging regulations, assessing business impact, and communicating changes. Quality and Risk Management includes supporting Quality Management Systems, participating in risk assessments and FMEA activities, contributing to continuous improvement, and supporting audits.

Requirements

• Bachelor's degree in Chemistry, Chemical Engineering, Biology, Toxicology, Environmental Science, Materials Science, Life Sciences, Engineering, or another related scientific discipline.
• Minimum five (5) years of experience in Regulatory Affairs, Product Stewardship, Environmental Health & Safety, Product Compliance, Quality, or related technical functions.
• Demonstrated experience supporting global regulatory compliance programs.
• Experience working 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.

Nice To Haves

• Experience supporting filtration, purification, laboratory, bioprocessing, diagnostics, medical device, pharmaceutical, or chemical products.
• Knowledge of global chemical regulations including TSCA, REACH, GHS, CLP, RoHS, PFAS, Food Contact, and Hazard Communication requirements.
• Experience supporting New Product Introduction (NPI) and product lifecycle management.
• Experience performing 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.
• Regulatory Affairs Certification (RAC), Certified Hazardous Materials Manager (CHMM), or other applicable professional certifications.

Responsibilities

• Develop and execute global regulatory strategies that support new product commercialization and lifecycle management.
• Interpret emerging global regulations and communicate regulatory impacts to business stakeholders.
• Provide regulatory guidance throughout product development, change management, and product discontinuation activities.
• Ensure compliance with applicable global chemical, environmental, product safety, and industry-specific regulations.
• Support regulatory submissions, product registrations, declarations of conformity, and compliance documentation where applicable.
• Lead product stewardship activities throughout the entire product lifecycle.
• Conduct product hazard, exposure, and risk assessments.
• Evaluate product composition for regulatory compliance and sustainability objectives.
• Partner with R&D and Product Management to identify regulatory risks early during product development.
• Develop mitigation strategies that balance regulatory compliance, customer expectations, and business objectives.
• Support responsible chemical management and sustainable product design initiatives.
• Provide expertise in applicable regulations including, but not limited to: TSCA, REACH and UK REACH, GHS and CLP, RoHS, Proposition 65, PFAS regulations, Food Contact regulations, Drinking Water regulations, Biocide regulations, Chemical inventory requirements, Hazard Communication standards, FDA and USP requirements, where applicable.
• Participate as the Regulatory Affairs and Product Stewardship representative on global product development teams.
• Support Stage Gate and design review processes.
• Review product claims, labels, instructions for use, technical literature, and marketing materials.
• Ensure regulatory requirements are incorporated into commercialization activities.
• Evaluate product changes for regulatory impact and coordinate required actions before implementation.
• Partner closely with Research & Development, Quality, Manufacturing, Operations, Environmental Health & Safety, Supply Chain, Procurement, Marketing, Sales, Legal, and Global Regulatory Affairs to ensure regulatory compliance while supporting business objectives and operational excellence.
• Respond to customer regulatory inquiries.
• Prepare compliance letters, declarations, certificates, and technical documentation.
• Support customer audits and regulatory assessments.
• Review customer questionnaires regarding product compliance and chemical content.
• Partner with Commercial teams to resolve customer regulatory concerns.
• Monitor emerging global regulations affecting products and markets.
• Assess business impact and develop implementation strategies.
• Communicate regulatory changes to leadership and cross-functional teams.
• Participate in industry associations and professional organizations to maintain current regulatory knowledge.
• Support Quality Management Systems including ISO 9001 and ISO 13485 where applicable.
• Participate in product risk assessments and Failure Mode and Effects Analysis (FMEA) activities.
• Contribute to continuous improvement initiatives that strengthen compliance and operational effectiveness.
• Support internal and external audits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior