- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designing and developing ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans + Assisting in the writing of regulatory applications to the FDA and other… more
- Beth Israel Lahey Health (Burlington, MA)
- …knowledge of specific protocols. Implements study protocols in accordance with regulatory , departmental and institutional requirements. Uses the nursing process to ... trials research adhering to Research SOPs, GCP compliance and FDA regulations. 2) Functions as a mentor, resource and...the EMR. + Performs data management duties ensuring strong quality of data. + Identifies data management issues with… more
- Atlantic Health System (Newton, NJ)
- …disruption. * Perform electrical safety testing and documentation per organizational and regulatory standards (eg, Joint Commission, NFPA 99, FDA , ACR). * ... and advanced fluoroscopy equipment. This role requires expert-level troubleshooting, regulatory compliance oversight, and leadership in supporting the imaging… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …processes, and standards in alignment with Good Clinical Practices (GCP) and applicable regulatory guidelines (eg, FDA , EMA, ICH). * Oversees the review of ... to CROs ensuring adherence to cost, timeline, and data quality requirements. * Participates in clinical vendor selection for...or supervisory role. * In-depth knowledge of CDM processes, regulatory standards ( FDA , EMA, ICH-GCP), and clinical… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …and ensures that information systems are secure and compliant with legal, regulatory , and contractual obligations. This role presents regularly to the Executive Team ... the information security function across the company to ensure consistent and high- quality information security management in support of the business goals. +… more
- J&J Family of Companies (Irvine, CA)
- …ensuring patient safety. Act as medical and/or technical expert in communications with FDA and other Regulatory agencies worldwide. Oversees post market clinical ... professional development. + Work closely with cross-functional teams, including R&D, Regulatory , Marketing, and Quality to support project prioritization,… more
- Sanofi Group (Morristown, NJ)
- …+ Contribute to the clinical part of Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc.) and answer to questions from health ... leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy… more
- J&J Family of Companies (San Diego, CA)
- …and regulatory requirements in partnership with nonclinical, statistical, clinical, regulatory , and quality colleagues. + Engage in development, evaluation, ... and implementation of generative Artificial Intelligence (AI) writing and Quality Control (QC) tools for regulatory document generation. + Collaborate with… more
- AbbVie (Irvine, CA)
- …requirements. + May coordinate and develop information for reports submitted to the FDA and Global Regulatory Authorities. + May initiate research projects ... and based on strong scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
- PCI Pharma Services (Bedford, NH)
- …SolidWorks, PLC & SCADA control system. + Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus. + Demonstrated ... activities in accordance with cGMP, EH&S, and the site quality systems. + Establish and streamline practices around equipment...Project, MS Power Point, + Knowledge of GMP and FDA regulatory requirements for drugs and/or medical… more
Recent Jobs
-
Senior Director of Infrastructure and Operations
- Keurig Dr Pepper (Frisco, TX)
-
Curriculum Developer for Contact Center Operations (San Antonio)
- Usaa (San Antonio, TX)
-
Talent Program Manager Senior - Performance Management & Potential (Charlotte)
- Usaa (Charlotte, NC)
-
IT/IS Risk Management & Governance Executive (Charlotte)
- Usaa (Charlotte, NC)