Thermo Fisher Scientific · 8 hours ago
Regulatory Affairs Specialist II
Cincinnati, OH
Full-time
Onsite
Entry, Mid Level
2+ years expThermo Fisher Scientific is a company dedicated to making a positive impact on a global scale. The Regulatory Affairs Specialist II is responsible for ensuring compliance with global regulatory requirements and U.S. DEA regulations, working cross-functionally to support product lifecycle management and regulatory submissions.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
Ensure regulatory compliance and market access for diagnostic and regulated products across global markets
Prepare, review, and maintain regulatory submissions and technical documentation in compliance with FDA, EU IVDR/MDR, and other regional regulations
Support product lifecycle management, including change control, product registrations, and post-market surveillance activities
Maintain compliance with quality management systems (ISO 13485, GMP, MDSAP)
Interpret and apply regulatory requirements to product development, manufacturing, and maintenance activities
Collaborate with cross-functional teams to support audits, inspections, and regulatory inquiries
Ensure site compliance with Title 21 Code of Federal Regulations (Part 1300–End) and Thermo Fisher corporate policies related to controlled substances
Coordinate receipt, storage, dispensing, shipment, and recordkeeping of controlled substances
Prepare and manage DEA documentation and reporting, including DEA-222 forms, ARCOS reports, Biennial Inventories, Quota Submissions, Computation Charts, and Year-End Reports
Monitor the Federal Register for changes in DEA regulations and assess site impact
Conduct periodic internal audits to ensure continuous DEA compliance and drive improvements
Build, review, and update SOPs related to DEA compliance and controlled substance activities
Develop and deliver DEA compliance training to site personnel
Act as a liaison to manufacturing and laboratory teams, spending significant time on the manufacturing floor to ensure alignment with regulatory and DEA requirements
Coordinate waste management, storage room maintenance, and controlled substance area compliance
Lead security-related activities for controlled substance areas, including investigations, alarm testing, access management, surveillance systems, and change control
Serve as a site subject matter expert for controlled substance security and compliance
Qualification
Required
HS Diploma with 4+ years of experience required
Strong working knowledge of FDA regulations, EU IVDR/MDR, DEA regulations (21 CFR Part 1300–End), and GMP
Experience with regulatory submissions, controlled substance documentation, and audits
Strong understanding of quality systems, change control, and product lifecycle management
Excellent written, verbal, and interpersonal communication skills
Strong organizational, project management, and problem-solving skills
Ability to work effectively in a matrixed, cross-functional environment with minimal supervision
Proficiency in Microsoft Office, ERP systems, and regulatory information management systems
Detail-oriented with strong documentation and analytical skills
Fluency in English required; additional languages beneficial
Must be legally authorized to work in the United States now and in the future, without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Preferred
Advanced Degree with no prior experience or Bachelor's Degree with a minimum of 2 years of experience in Regulatory Affairs, DEA compliance, pharmaceutical manufacturing, quality, or a related regulated industry highly preferred
Preferred fields of study: Life Sciences, Chemistry, Pharmacy, Engineering, Biology, Microbiology, or related scientific field
Experience in IVD, medical device, pharmaceutical, or controlled substance environments strongly preferred
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
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