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New · posted Oct 23

Thermo Fisher Scientific · Biotechnology

Regulatory and Product Steward Specialist

  • St Paul, MN
  • On-site
  • Full-time
  • Associate & Specialist
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Pay$76K–$101Ka year · employer provided
ScheduleMon–Fri
LocationSt Paul, MNOn-site
LevelAssociate & Specialist
FunctionRegulatory AffairsRegulatory
Deadline

Open until filled

The role

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.

What you need

  • 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.

Physical Requirements

Primarily office-based with occasional laboratory or manufacturing environment interaction.

Preferred Qualificationsnice to have

  • 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.

Skills named in this posting

What you'll do

Regulatory Strategy & Compliance

  1. Develop and execute global regulatory strategies that support new product commercialization and lifecycle management.
  1. Interpret emerging global regulations and communicate regulatory impacts to business stakeholders.
  1. Provide regulatory guidance throughout product development, change management, and product discontinuation activities.
  1. Ensure compliance with applicable global chemical, environmental, product safety, and industry-specific regulations.
  1. Support regulatory submissions, product registrations, declarations of conformity, and compliance documentation where applicable.

Product Stewardship

  1. Lead product stewardship activities throughout the entire product lifecycle.
  1. Conduct product hazard, exposure, and risk assessments.
  1. Evaluate product composition for regulatory compliance and sustainability objectives.
  1. Partner with R&D and Product Management to identify regulatory risks early during product development.
  1. Develop mitigation strategies that balance regulatory compliance, customer expectations, and business objectives.
  1. Support responsible chemical management and sustainable product design initiatives.

Global Regulatory Compliance

Provide expertise in applicable regulations including, but not limited to:

  1. TSCA
  1. REACH and UK REACH
  1. GHS and CLP
  1. RoHS
  1. Proposition 65
  1. PFAS regulations
  1. Food Contact regulations
  2. Biocide regulations
  1. Chemical inventory requirements
  1. Hazard Communication standards
  1. FDA and USP requirements, where applicable

Cross-Functional Collaboration

Partner closely with:

  1. Research & Development
  1. Quality
  1. Manufacturing
  1. Operations
  1. Environmental Health & Safety
  1. Supply Chain
  1. Procurement
  1. Marketing
  2. Legal
  1. Global Regulatory Affairs

to ensure regulatory compliance while supporting business objectives and operational excellence.

Customer & Commercial Support

  1. Respond to customer regulatory inquiries.
  1. Prepare compliance letters, declarations, certificates, and technical documentation.
  1. Support customer audits and regulatory assessments.
  1. Review customer questionnaires regarding product compliance and chemical content.
  1. Partner with Commercial teams to resolve customer regulatory concerns.

Regulatory Intelligence

  1. Monitor emerging global regulations affecting Thermo Fisher products and markets.
  1. Assess business impact and develop implementation strategies.
  1. Communicate regulatory changes to leadership and cross-functional teams.
  1. Participate in industry associations and professional organizations to maintain current regulatory knowledge.

Quality & Risk Management

  1. Support Quality Management Systems including ISO 9001 and ISO 13485 where applicable.
  1. Participate in product risk assessments and Failure Mode and Effects Analysis (FMEA) activities.
  1. Contribute to continuous improvement initiatives that strengthen compliance and operational effectiveness.
  1. Support internal and external audits.

Pay and benefits

$75,800 – $101,000 a year

Employer provided
How this compares

The 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

  • Medical, dental and vision plans

  • Paid time off and 10 paid holidays

  • Paid parental leave

  • 401(k) retirement savings plan

  • Employee Stock Purchase Plan

  • Tuition reimbursement

Where you'll work

St Paul, MNOn-siteOpen in Maps (opens in a new tab)

More jobs in St Paul, MN

Schedule and working conditions

Days

Shift5 days a week

Standard (Mon-Fri)

Environmental Conditions

Office

Job intelligence

The context around this role

Live data · October 23, 2026

Salary intelligence

How the pay compares

This role's midpoint is 4% below the US median for Regulatory Affairs roles at this level.

This roleEmployer provided

$75,800 to $101,000 a year

Associate & Specialist roles in the US32 roles publishing pay

Middle half $83,750 to $95,125, median $91,750
Annual base pay
Annual base payLowMedianHigh
This role$75,800—$101,000
All US$83,750$91,750$95,125

This role: Thermo Fisher Scientific's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory Affairs

The general path across 315 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.

  1. This role

    Associate & Specialist

    Often: Regulatory Affairs Specialist · Summer 2027 Internship

    $92K median39 open

  2. Next step

    Senior & Principal

    Often: Senior Regulatory Affairs Specialist · Principal Regulatory Affairs Specialist

    $138K median75 open

  3. Later

    Manager

    Often: Regulatory Affairs Manager · Manager, Regulatory Affairs

    $161K median68 open

  4. Later

    Director

    Often: Senior Director, Regulatory Affairs · Director, Regulatory Affairs

    $236K median116 open

  5. Later

    VP & Executive

    Often: Global Head of Injectable Aesthetics Regulatory Strategy · Global Head of Regulatory Affairs, Roche Diagnostics

    $323K median17 open

Career resources on Regulatory Affairs

Skills DNA

What this role leans on

How many of the posting's 73 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 21 linesLab testing and methods: 3 linesDocumentation and SOPs: 3 linesRegulatory submissions: 1 lineQuality systems and risk: 8 linesCollaboration and leadership: 11 linesGMPLab testingDocumentationSubmissionsQuality systemsTeamwork
  • GMP and compliance21
  • Collaboration and leadership11
  • Quality systems and risk8
  • Lab testing and methods3
  • Documentation and SOPs3
  • Regulatory submissions1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

Thermo Fisher on Regulatory Jobs

87
Open roles
74
Distinct roles
36
Locations

By discipline

  • Quality78 90%
  • Regulatory7 8%
  • Compliance & Safety2 2%

By level

  • Senior & Principal35 40%
  • Associate & Specialist27 31%
  • Manager20 23%
See all 87 Thermo Fisher roles

More roles at Thermo Fisher

All 87 Thermo Fisher roles

Similar Regulatory Affairs roles elsewhere

Regulatory and Product Steward Specialist at Thermo Fisher

Open until filled. $76K–$101K a year, employer provided.

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