Thermo Fisher Scientific · 2 hours ago
Regulatory Affairs/Product Steward Specialist
Saint Paul Church, MN
Full-time
Onsite
Mid, Senior Level
$76K/yr - $114K/yr
5+ years expThermo Fisher Scientific is a company dedicated to making the world healthier, cleaner, and safer. They are seeking a Regulatory Affairs/Product Steward Specialist to ensure compliance with global regulations and provide strategic regulatory guidance for product development and lifecycle assessments. The role involves collaborating with cross-functional teams to implement regulatory strategies while serving as a liaison with internal and external stakeholders.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Provide strategic regulatory and Product Stewardship guidance and expertise for product development, change management, registration, and lifecycle assessments across Filtration and Separation Division's portfolio
Collaborate with cross-functional teams to develop and implement regulatory strategies that enhance time-to-market while maintaining the highest standards of compliance
Serve as a key liaison with internal stakeholders and external partners to achieve successful outcomes
Qualification
Required
Bachelor's degree or higher in a science or engineering discipline plus 5 years of experience in regulatory affairs in the EHS&R, environmental sciences, quality, technical field, pharmaceutical, or medical device
Strong knowledge of global regulatory requirements and regulatory compliance experience in one or more of the following areas: regional and global article and chemical regulations including but not limited to TSCA, REACH, RoHS; conflict minerals, consumer product safety laws, hazard communication, biocide regulations, global food contact regulations and regulations impacting biopharmaceutical manufacturers such as FDA and USP
Experience conducting product life cycle assessments or product risk assessments for new product commercialization and existing product changes
Demonstrated success in regulatory strategy development and implementation
Understanding of quality systems including ISO 9001 and ISO 134875 and risk management principles
Demonstrated risk-based decision-making skills
Excellent project management skills with ability to manage multiple projects simultaneously
Strong analytical and problem-solving capabilities
Clear written and verbal communication skills
Experience working effectively in cross-functional team environments
Fluency in English required; additional languages beneficial
Proficiency with Microsoft Office suite
Strong attention to detail and organizational skills
Ability to interpret and apply complex regulatory requirements
Customer-focused mindset with business acumen
Available for occasional travel (10-20%)
Effective interpersonal skills and ability to build consensus
Preferred
life sciences
chemistry
engineering
pharmacy
or related scientific field
Benefits
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
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Michel Lagarde
Chief Operating Officer
Recent News
CB Insights
2026-01-23
Company data provided by crunchbase