Regulatory Affairs Specialist III
hace 4 días
Saint Paul
Job Description Job Title: Regulatory Affairs Specialist III Location: Maplewood MN 55119 Duration: 18 months Virtual interview, Monday thru Friday, 8:00-5:00, Can be flexible on work hours, Hybrid on site When you're part of Thermo Fisher Scientific, 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. 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 Thermo Fisher 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 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. 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. Company Descriptionw3r Consulting is an award-winning, best-in-class Healthcare, Nursing consulting and management company.w3r Consulting is an award-winning, best-in-class Healthcare, Nursing consulting and management company.