Regulatory and Product Steward Specialist

Thermo Fisher Scientific•Maplewood, MN
•$75,800 - $101,000

About The Position

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. 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, and provides guidance across product development, change management, and discontinuation. It also leads product stewardship activities, evaluates product composition and risks, supports sustainable product design, and collaborates with teams across the organization. The specialist responds to customer regulatory inquiries, prepares compliance documentation, supports customer audits and assessments, monitors regulatory developments, and contributes to quality, risk management, and continuous improvement activities. The role is primarily office-based, with occasional interaction in laboratory or manufacturing environments.

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.
  • 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.

Responsibilities

  • Develop and execute global regulatory strategies for new product commercialization and lifecycle management.
  • Interpret emerging global regulations and communicate their impacts to business stakeholders.
  • Provide regulatory guidance during product development, change management, and product discontinuation.
  • 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.
  • Evaluate product composition for regulatory compliance and sustainability objectives.
  • Partner with R&D and Product Management to identify regulatory risks during product development.
  • Develop mitigation strategies balancing regulatory compliance, customer expectations, and business objectives.
  • Support responsible chemical management and sustainable product design initiatives.
  • Collaborate with cross-functional teams to support regulatory compliance and business objectives.
  • Respond to customer regulatory inquiries and prepare compliance letters, declarations, certificates, and technical documentation.
  • Support customer audits and regulatory assessments and review customer questionnaires concerning 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).
  • 10 paid holidays annually.
  • Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.
  • Accident and life insurance.
  • Short- and long-term disability in accordance with company policy.
  • Competitive 401(k) U.S. retirement savings plan.
  • Employees’ Stock Purchase Plan (ESPP), with eligible colleagues able to purchase company stock at a discount.
  • Variable annual bonus may be available based on company, team, and/or individual performance.
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