Regulatory and Product Steward Specialist

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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:

• Bachelors 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 Benefits

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: Experience:

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