- Terumo Medical Corporation (Somerset, NJ)
- …+ Ongoing collaboration with medical, regulatory and legal partners to assure compliance with FDA regulations US laws and appropriate clinical representation ... effective communication materials. + Demonstrate a commitment to patient safety and product quality by maintaining compliance with all TMC Quality Systems… more
- Integra LifeSciences (Plainsboro, NJ)
- …established costs, quality , and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... and maintenance problems to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all… more
- Integra LifeSciences (Plainsboro, NJ)
- …established costs, quality , and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... and maintenance problems to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all… more
- Lilly (Branchburg, NJ)
- …documented processes and procedures are in place for all activities to meet quality and compliance standards. Experience with GMP regulations. + Must assist ... production processes with business systems to optimize manufacturing efficiency, quality , and safety. + Must have a strong understanding...and data analytics. + Ensure MES system is in compliance with industry-specific regulations, such as FDA … more
- Merck (Trenton, NJ)
- …lead the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently ... with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. **Primary… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance , R&D quality and fit-for-purpose to both Gilead business needs and ... oversight and completion of assigned tasks. + Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …advanced degree in life sciences/related fields with significant experience in quality compliance or related fields. **PREFERRED QUALIFICATIONS:** **U.S. ... quality capabilities, enhance process improvements and transparency. This is a quality assurance role, helping maintain global compliance , reinforcing audit… more
- Actalent (Princeton, NJ)
- …management of clinical trials across multiple phases. This role ensures compliance with regulatory requirements, timelines, and budget constraints while driving ... + Collaborate with regulatory teams for submissions, amendments, and compliance -related documentation. + Address protocol deviations, audit findings, and inspection… more
- Sumitomo Pharma (Trenton, NJ)
- …rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop ... goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and… more
- Integra LifeSciences (Princeton, NJ)
- …execute the requirements of Unique Device Identification (UDI) regulations for on-going global compliance (eg, FDA GUDID, EUDAMED, AUSUID etc.). + Develop and ... performing data analysis, managing data uploads and verification, and ensuring high- quality , timely support for the Global Regulatory Affairs function and broader… more