- Caldera Medical (Westlake Village, CA)
- …submit and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU ... regulatory licensing by jurisdictions. * Work cross-functionally with R&D, Quality, Clinical , and Marketing teams to ensure regulatory requirements are met… more
- System One (Florham Park, NJ)
- …application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the ... documents for electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs, Clinical Development, and Quality Assurance, to… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …in the development and use of dashboards and performance metrics to track regulatory compliance 2. Utilize data to identify trends, gaps, and opportunities ... required + Experience + Minimum of 5-7 years of experience in healthcare regulatory compliance , accreditation readiness, or quality improvement within a hospital… more
- Abbott (Santa Clara, CA)
- …based upon regulatory changes + Support pre and post approval clinical strategy and submission activities + Anticipate regulatory obstacles and emerging ... with US and global product post marketing approval requirements + Evaluate proposed clinical and manufacturing changes for regulatory filing strategies + Execute… more
- Ascendis Pharma (Palo Alto, CA)
- …and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation ... implementing global regulatory strategies with focus on America's and the clinical , and non- clinical disciplines. Ensures timely preparation of organized and… more
- Trinity Health (Silver Spring, MD)
- …and staff to maintain survey readiness and promote a culture of continuous regulatory compliance and quality improvement. **Job Title: Regulatory , ... teams to implement quality improvement initiatives to enhance patient safety and regulatory compliance . + Maintain current knowledge of changes in healthcare… more
- Abbott (Santa Clara, CA)
- …submission and approval requirements. + Participate in risk-benefit analysis for regulatory compliance . **Premarket:** + Assess the acceptability of quality, ... regulatory review. + Monitor and submit applicable reports to regulatory authorities. + Evaluate proposed preclinical, clinical and manufacturing changes… more
- Bausch Health (Bothell, WA)
- …changes. Risk Management and Reporting + Conduct risk assessments related to regulatory compliance , helping the company identify potential non- compliance ... affairs team and other departments, such as R&D, clinical , quality assurance, manufacturing, and marketing, to ensure that...highlighting regulatory achievements and potential risks. Global Regulatory Compliance + Ensure compliance … more
- BayCare Health System (Clearwater, FL)
- …built on a foundation of trust, dignity, respect, responsibility, and clinical excellence. **Title:** Research Regulatory Specialist **Facility:** BayCare ... assigned research team members, investigators and associated portfolio of clinical research projects are in compliance with...regulatory master files for industry & investigator initiated clinical trials + Aid in the development of protocol… more
- Rochester Regional Health (Rochester, NY)
- …records, and helping implement new technologies and protocols. This position ensures regulatory compliance , improves clinical workflow efficiency, and allows ... the delivery of safe and effective radiation therapy by performing technical and clinical tasks under the supervision of a licensed medical physicist and a certified… more