- CSL Behring (King Of Prussia, PA)
- …or reject promotional programming based on US Code of Federal Regulations and FDA implementing regulations and guidance. + Adhere to related SOPs and work ... based on company practice, CSL policy, US law, and FDA regulations. + Collaborate with Commercial Operations Marketing, Legal,...and submit advertising and promotional labeling materials to the FDA as required under 21 CFR 314.81(b)(3)(i) or 21… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …strategies, preparing and submitting complex pre-market and post-market applications to FDA , EU Notified Bodies, and other international authorities, and managing ... Prepares and files complex pre-market and post-market regulatory submissions with the US FDA , Notified Bodies in the EU and other international regulatory bodies, as… more
- AbbVie (North Chicago, IL)
- …business activities and operations. + Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA ... Advise internal customers who may contribute to regulated communication on Regulatory/ FDA issues including Public Affairs, Clinical Development, Legal, and others… more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This ... product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project...Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + Partnering with the… more
- Cardinal Health (Mansfield, MA)
- …(LIMS), such as LabWare. + Possesses significant working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing. + ... or testing environment, preferred. + Strong knowledge of ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other pharmaceutical regulatory… more
- Hologic (Marlborough, MA)
- …implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you ... lasting impact on patient safety and innovation. **Knowledge** + Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO standards (eg, ISO… more
- Reckitt (Evansville, IN)
- …knowledge, and capabilities required to operate in a highly regulated, FDA -compliant environment. The successful candidate will oversee the development and ... cross-functional teams (Quality, Operations, HR, EHS) to ensure training programs meet FDA and other regulatory standards. + Partner with Supply and HR Leadership… more
- Abbott (Alameda, CA)
- …Implement approved design control procedures for software development in accordance with FDA guidelines. + Play a critical role in software development projects, ... + Solid knowledge of regulations for medical device development, (EN460001, ISO13485, FDA ) is desirable. + Experience in model based design (UML or SysML),… more
- Stanford University (Stanford, CA)
- …events and ensure timely regulatory filing. Ensure compliance with HIPAA, GCP, and FDA regulations as applicable. + Own operational readiness for trial launch and ... executing randomized controlled trial treatment studies. + Experience with FDA regulatory procedures and reporting. + Demonstrated experience with regulatory… more
- NTT DATA North America (Pittsburgh, PA)
- …with PMO governance, documentation standards, and regulatory requirements (eg, FDA CSV). Drive continuous improvement by identifying opportunities to streamline ... Experienced in delivering projects in regulated environments, ensuring compliance with FDA Computer Systems Validation (CSV) and quality standards. Led process… more