Thermo Fisher Scientific · 1 day ago
Sr. Regulatory Affairs Specialist
Pittsburgh, PA
Full-time
Onsite
Senior Level
6+ years expThermo Fisher Scientific is a global leader in serving science, and they are seeking a Senior Regulatory Affairs Specialist. In this role, you will provide strategic guidance on regulatory pathways, manage submissions, and collaborate with cross-functional teams to develop and implement regulatory strategies for the commercialization of advanced products.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Provide strategic guidance on regulatory pathways
Manage submissions
Serve as a subject matter expert on various regulations across multiple jurisdictions
Help develop and implement regulatory strategies that enable successful commercialization of advanced products
Conduct daily comprehensive regulatory reviews of new products
Organize and validate device data for submission and registration with the FDA GUDID database
Develop and implement regulatory strategy
Interpret and apply complex regulatory requirements
Work effectively in cross-functional team environments
Manage multiple projects simultaneously
Ensure compliance with applicable federal, state, and international regulations
Participate in change control and post-market surveillance activities
Demonstrate strong analytical and problem-solving capabilities
Communicate clearly in written and verbal formats
Maintain strong attention to detail and organizational skills
Adopt a customer-focused mindset with business acumen
Be available for occasional travel (5%-10%)
Qualification
Required
Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in regulatory affairs in the pharmaceutical, medical device, or diagnostics industry
Experience with product compliance with applicable federal, state, and international regulations, including 21 CFR Part 820 and National Association of Boards of Pharmacy (NABP) regulations
Strong knowledge of global regulatory requirements, particularly FDA, EU MDR/IVDR, and other major markets' regulations
Knowledge of internal screening processes to conduct daily comprehensive regulatory reviews of new products
Experience with organizing and validating device data for submission and registration with the FDA GUDID database
Demonstrated success in regulatory strategy development and implementation
Expert understanding of quality systems (ISO 13485, GMP/QSR) and risk management principles
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
Experience with change control and post-market surveillance activities
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 (5%-10%)
Preferred
Preferred Fields of Study: life sciences, chemistry, engineering, pharmacy, or related scientific field
Additional certifications like RAC (Regulatory Affairs Certification) advantageous
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
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
2026-01-09
Research & Development World
2026-01-09
EIN Presswire
2026-01-07
Company data provided by crunchbase