- Danaher Corporation (New York, NY)
- …role, you will have the opportunity to: + Develop and execute global regulatory strategies, including FDA 510(k), Pre-Submissions, Health Canada filings, and ... teams, contributing regulatory intelligence and strategic input. + Engage with regulatory authorities (eg, FDA , Health Canada) and support external audits… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and… more
- University of Pennsylvania (Philadelphia, PA)
- … Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable ... NCI and the FDA , as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Specialist-CC is expected… more
- Sumitomo Pharma (Lincoln, NE)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …on submissions and other issues. + Independently reviews product changes to ensure regulatory compliance , including assessment of impact to US and CE Mark ... documentation and product labeling in consideration of US, EU, and other global regulatory requirements. + Authors FDA submissions, EU technical files, and other… more
- Beth Israel Lahey Health (Boston, MA)
- …not just taking a job, you're making a difference in people's lives.** The Regulatory Specialist supports regulatory compliance for clinical research at Beth ... deviations and submission of other study documents to support regulatory compliance and troubleshoots processes and procedures...+ Preparation and submission of annual reports to the FDA ; submission of regulatory documents to NIH/OBA,… more
- Fresenius Medical Center (Waltham, MA)
- …of pharmaceutical products. + Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory ... advocate for regulatory positions, influence decisions, and expedite approvals. + Regulatory Risk Management & Compliance : + Identify and manage … more
- Abbott (Plymouth, MN)
- … affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory ... or modified, are distributed to appropriate personnel. + Reviews device labeling for compliance with FDA submissions and applicable regulations. + Supports the… more
- System One (Malvern, PA)
- …and reporting globally. + Perform duties as the main Regulatory Contact for FDA , Person Responsible for Regulatory Compliance , or "PRRC" (per EU MDR), ... + Manage Regulatory and Medical Affairs SOPs to ensure full compliance with global regulatory requirements. + Maintain current knowledge of changes… more
- Sumitomo Pharma (Madison, WI)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and… more
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