Regulatory Affairs Specialist II

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 dayenabling our customers to make the world healthier cleaner and safer.

The Regulatory & DEA Compliance Specialist II is responsible for ensuring compliance with global regulatory requirements and U.S. Drug Enforcement Administration (DEA) regulations for diagnostic and controlled substance-related activities at the Cincinnati site. This role works cross-functionally with Regulatory Affairs Quality Manufacturing Development Security and Operations to support product lifecycle management regulatory submissions controlled substance handling and site security processes.

This position requires strong regulatory knowledge hands-on operational engagement critical thinking and the ability to manage multiple compliance programs simultaneously.

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Key Responsibilities

Regulatory Affairs & Product Compliance

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.

DEA Compliance & Controlled Substances

Ensure site compliance with Title 21 Code of Federal Regulations (Part 1300End) 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.

Operations & Security Support

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.

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Education & Experience

Advanced Degree with no prior experience or Bachelors Degree with a minimum of 2 years of experience in Regulatory Affairs DEA compliance pharmaceutical manufacturing quality or a related regulated industry highly preferred. HS Diploma with 4 years of experience required.

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.

Equivalent combinations of education training and relevant experience will be considered.

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Knowledge Skills and Competencies

Strong working knowledge of FDA regulations EU IVDR/MDR DEA regulations (21 CFR Part 1300End) 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.

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OTHER

• Relocation assistance is not provided.
• 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.