- Philips (Cambridge, MA)
- …creating successful submission(s) of AI-enabled solutions, or evaluating AI submissions at the regulatory side ( FDA ) would be a plus. + Your skills include: ... at external events in the USA. + Monitor AI regulatory developments in the USA on state and federal...won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work… more
- System One (Ozark, MO)
- …resolution and encourage a solution-oriented approach among team members. 6. Compliance and Quality Assurance + Ensure adherence to FDA , ICH-GCP, and sponsor ... requirements for all studies. + Conduct internal quality checks on documentation, data entry, and ... quality checks on documentation, data entry, and regulatory files. + Develop and implement corrective and preventive… more
- Penn Medicine (West Chester, PA)
- …services, and technologies, ensuring that clinical input and safety, regulatory , and epidemiological considerations are incorporated before decisions are made. ... + Continuously communicates at all levels the importance of patient satisfaction, quality of care, and sound financial performance and champions successes and… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide. Position ... and continuous improvement initiatives that directly support the reliability and regulatory integrity of site operations. This role ensures that maintenance and… more
- Caldera Medical (Salt Lake City, UT)
- … regulatory standards ( FDA , ISO 13485, EU MDR, etc.). Partner with regulatory and quality teams to sustain approvals and readiness for audits. Operations ... , scalability, and cost efficiency. Cross-Functional Collaboration Work closely with R&D, Quality , Regulatory , Finance, HR, and the Executive Leadership Team to… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for ... programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation;… more
- ThermoFisher Scientific (Wilmington, NC)
- … submissions (if appropriate) are addressed. + Ensures that essential document quality meets the expectation of Regulatory Compliance Review. + Reviews ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
- University of Miami (Miami, FL)
- …no typographical errors, is consistent with source documents, and follows external sponsor/ regulatory requirements. 25. Ensures data quality and integrity in ... study execution, program and operations management, staff development, and regulatory compliance. The position supports cross functional research efforts and… more
- Pfizer (Groton, CT)
- …Chief Medical Office colleagues to address asset team evidence needs and support global regulatory submissions to the FDA , EMA and other agencies. + Deliver ... I&I products. The Senior Manager will also be accountable for the quality , timeliness, and efficiency of all RWE/Epi deliverables in assigned product/disease area,… more
- BD (Becton, Dickinson and Company) (Columbus, NE)
- …planning - Proficient + Computer skills - Proficient + Working knowledge of FDA regulations & other medical device regulatory compliance requirements - ... activities to ensure the safety of associates, high product quality standards and production schedules are met so the...support the site ramp up plan. Ensure compliance with regulatory policies and standard: manage compliance activities to ensure… more