Regulatory and Product Steward Specialist

Thermo Fisher Scientific • Maplewood, MN

2d • Onsite

About The Position

As a Regulatory Affairs & Product Stewardship Specialist within Thermo Fisher Scientific’s Filtration & Separation business, you will support regulatory and product stewardship activities for a diverse portfolio of filtration, purification, bioprocessing, and life sciences products. The role helps ensure products remain compliant, safe, and sustainable throughout their lifecycle while supporting business growth, innovation, and customer success.

The position develops and executes global regulatory strategies for product commercialization and lifecycle management; interprets emerging regulations; provides guidance across product development, change management, and discontinuation; and supports applicable submissions, registrations, declarations, and compliance documentation. It leads product stewardship work, including hazard, exposure, and risk assessments, composition reviews, mitigation planning, responsible chemical management, and sustainable product design.

The specialist collaborates with technical, operational, commercial, and legal teams; responds to customer regulatory questions; prepares compliance documentation; supports customer assessments and audits; monitors regulatory developments; and contributes to quality systems, risk management, audits, and continuous improvement. The role is primarily office-based, with occasional interaction in laboratory or manufacturing environments. The stated Minnesota salary range is $75,800–$101,000, with possible eligibility for a variable annual bonus.

Requirements

• Bachelor’s degree in Chemistry, Chemical Engineering, Biology, Toxicology, Environmental Science, Materials Science, Life Sciences, Engineering, or another related scientific discipline.
• At least five 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 in a fast-paced global environment.

Nice To Haves

• 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.

Responsibilities

• Develop and execute global regulatory strategies supporting new product commercialization and lifecycle management.
• Interpret emerging global regulations and communicate their impacts to business stakeholders.
• Provide regulatory guidance through product development, change management, and product discontinuation.
• Help 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 product lifecycle.
• Conduct product hazard, exposure, and risk assessments and evaluate product composition for regulatory compliance and sustainability objectives.
• Partner with Research & Development and Product Management to identify regulatory risks early and develop mitigation strategies.
• Support responsible chemical management and sustainable product design initiatives.
• Collaborate with Research & Development, Quality, Manufacturing Operations, Environmental Health & Safety, Supply Chain, Procurement, Marketing, Legal, and Global Regulatory Affairs.
• Respond to customer regulatory inquiries and prepare compliance letters, declarations, certificates, and technical documentation.
• Support customer audits and regulatory assessments; review customer questionnaires on product compliance and chemical content.
• Partner with Commercial teams to resolve customer regulatory concerns.
• Monitor emerging global regulations, assess business impacts, develop implementation strategies, and communicate 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 and support internal and external audits.

Benefits

• 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 of paid time off (PTO) and 10 paid holidays annually.
• Paid parental leave, including 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, including a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.
• Potential eligibility for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

What This Job Offers

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