Fda Jobs in Raleigh, NC (NOW HIRING)

IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11) * Note: these requirements do not apply for research positions. Preferred Qualifications: * PhD in Molecular Biology, Biochemistry ...

The Regulatory Affairs Specialist II provides regulatory leadership to support the compliance and safety of Clorox's FDA-regulated Foods portfolio, including U.S. and Canada regulatory requirements ...

Ensure compliance with FDA, cGDP requirements and applicable regulations for wholesale distribution acting as Responsible Person * Maintain compliance with the Drug Supply Chain Security Act (DSCSA ...

Ensure compliance with FDA, cGDP requirements and applicable regulations for wholesale distribution acting as Responsible Person * Maintain compliance with the Drug Supply Chain Security Act (DSCSA ...

Develop and optimize automated submission pipelines for FDA and global regulatory authorities * Ensure compliance with GxP, 21 CFR Part 11, HIPAA, and ICH E6 guidelines Data Engineering & Automation

S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory ...

S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory ...

Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings * Mentor, develop and act as a trusted advisor to coach members of the ...

Working knowledge of FDA regulations, cGMP, and validation lifecycle requirements.

Responsible for preparation and timely submissions of MDR/Vigilance reports to FDA/Competent Authorities and other regulatory agencies. Where necessary, seek and document relevant additional ...

Develops FDA-compliant XML labeling documents for submission in accordance with GSK or FDA timelines. * Works with internal Drug Listing experts to coordinate Drug Listing submissions via XML ...

S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory ...

Responsible for preparation and timely submissions of MDR/Vigilance reports to FDA/Competent Authorities and other regulatory agencies. Where necessary, seek and document relevant additional ...

Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings * Mentor, develop and act as a trusted advisor to coach members of the ...

Develops FDA-compliant XML labeling documents for submission in accordance with GSK or FDA timelines. * Works with internal Drug Listing experts to coordinate Drug Listing submissions via XML ...

... GxP, FDA, etc.), and adherence to company SOPs. • Perform system testing, validation, and documentation according to defined protocols. • Participate in upgrades, patches, and performance ...

Ensure automation systems comply with FDA 21 CFR Part 11, cGMP, GAMP 5, and data integrity requirements. * Support long-term reliability improvements and continuous process optimization.

Partner with QA/RA to ensure all R&D activities adhere to ISO 13485, FDA 21 CFR Part 820, and GMP standards * Develop schedule and budget estimates, and take responsibility for achieving technical ...

Ensure automation systems comply with FDA 21 CFR Part 11, cGMP, GAMP 5, and data integrity requirements. * Support long-term reliability improvements and continuous process optimization.

This role requires hands-on technical expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The Senior CQV Engineer will work cross ...