Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice
Job DescriptionAs 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.
DESCRIPTION: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 ResponsibilitiesRegulatory 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:
- Food Contact regulations
- Biocide regulations
- Chemical inventory requirements
- Hazard Communication standards
- FDA and USP requirements, where applicable
Cross-Functional Collaboration Partner closely with:
- Environmental Health & Safety
- 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.
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.
- Knowledge of global chemical regulations including TSCA, REACH, GHS, CLP, RoHS, PFAS, Food Contact, and Hazard Communication requirements.
- 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.
- 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.
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.
Physical Requirements Primarily office-based with occasional laboratory or manufacturing environment interaction.
Compensation and BenefitsThe salary range estimated for this position based in Minnesota is $75,800.00-$101,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
