Regulatory Affairs Specialist III
Listed on 2026-07-19
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Regulatory Affairs Specialist III
When you're part of ***, you'll do challenging work while collaborating with a team that values performance, quality, innovation, and continuous improvement. Our global organization enables our customers to make the world healthier, cleaner, and safer by delivering industry-leading technologies and solutions.
As a Regulatory Affairs & Product Stewardship Specialist 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.
Key Responsibilities:Regulatory Strategy & Compliance
- 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.
- Product Stewardship
- 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
- 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 Client 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.
Risk Management:
- 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.
- 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.
- Experience supporting filtration, purification, laboratory, bioprocessing, diagnostics, medical device, pharmaceutical, or chemical products.
- Knowledge…
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