- Alameda Health System (Oakland, CA)
- …for providing strategic oversight of department-wide education, clinical competencies, quality assurance, regulatory compliance, PACS/RIS workflow support, and ... items, and represents Diagnostic Imaging in interdepartmental initiatives involving IT, Quality , Education, Compliance, and Regulatory Affairs. **DUTIES &… more
- Abbott (Atlanta, GA)
- …peers understand quality system requirements and how they impact product quality and regulatory compliance. + Represents the division within Abbott through ... the audit results. + Analyze trends from various sources and proactively address regulatory , compliance, and quality issues. + Actively participate in FDA… more
- University of Colorado (Aurora, CO)
- …ASHI, FACT, and AATB and leads internal audits to ensure compliance. + Oversees quality assurance in compliance with strict regulatory standards to make sure ... (OFI) through audits and occurrence reports to the Director of Regulatory Affairs and/or Quality Manager, which are then shared with ClinImmune management and… more
- Community Health Systems (Bullhead City, AZ)
- …and implementation of the hospital's performance improvement plan, ensuring alignment with quality and regulatory standards. + Serve as a quality ... compliance. + Provide education to hospital staff and medical teams on quality standards, performance improvement methodologies, and regulatory updates. +… more
- Sanofi Group (Framingham, MA)
- …Authorities **Manage CMC documentation and submissions** + Write, prepare, review, and approve regulatory CMC dossiers + Ensure dossiers meet quality standards + ... **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA Waltham,...secure timely approvals while maintaining the highest standards of quality and compliance, ultimately supporting Sanofi's goal of bringing… more
- Medtronic (Minneapolis, MN)
- …guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards. + **Strong Communication Skills:** Excellent ... years of industry experience, with at least 2-3 years in regulatory , clinical, or quality roles. + Advanced degree in a scientific discipline (engineering,… more
- Houston Methodist (Houston, TX)
- …of regulatory and/or important safety related issues. + Perform high quality clinical review of regulatory forms and associated documentation (during ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating...assist in the preparation of periodic reports for FDA. ** QUALITY /SAFETY ESSENTIAL FUNCTIONS** + Provide routine updates and reporting… more
- J&J Family of Companies (Raynham, MA)
- …priorities. + Help establish formal escalation processes to surface issues of product quality , regulatory compliance, and quality systems. + Delivers ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** R&D/Scientific Quality **Job Category:**… more
- Lilly (IN)
- …training is structured, deployed, and measured across the organization. + Integrate regulatory and quality expectations into learning standards in partnership ... executed with operational excellence. + CoE becomes a trusted partner to Quality , Regulatory , and Business leaders. + Systems and content are digitally enabled… more
- Cordis (Irvine, CA)
- …that address unmet and critical medical needs. **Responsibilities** The **Senior Engineer, Quality Manufacturing** , joining the Quality team, will be ... for ensuring that our medical devices meet the highest quality standards throughout the manufacturing process. You will be...ensure the safety and efficacy of medical devices. + Regulatory Compliance: Stay up to date with regulatory… more