Regulatory and Product Steward Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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.

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 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
• Biocide regulations

• Chemical inventory requirements

• Hazard Communication standards

• FDA and USP requirements, where applicable

Cross-Functional Collaboration

Partner closely with:

• Research & Development

• Quality

• Manufacturing

• Operations

• Environmental Health & Safety

• Supply Chain

• Procurement

• Marketing
• 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.

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.

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