Regulatory Affairs Specialist III

Job Description

Job Summary:

• When you’re part of client, 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.

Duties and 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.

Global Regulatory Compliance:

• 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

New Product Introduction (NPI):

• 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.

Cross-Functional Collaboration 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.

Customer & Commercial Support:

• 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.

Regulatory Intelligence:

• 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.

Quality & 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.

Minimum Qualifications:

• 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.

Preferred Qualifications:

• 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 s upporting 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.

Competencies:

• Successful candidates demonstrate:
• Strong scientific and technical judgment.
• Excellent problem-solving and risk assessment skills.
• Customer-focused decision making.
• Ability to influence without authority across global organizations.
• Strong collaboration and relationship-building skills.
• Effective communication with technical and non-technical audiences.
• Continuous improvement mindset.
• Ability to balance compliance, innovation, and business objectives.