- 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
- University of Pennsylvania (Philadelphia, PA)
- …Specialist C, prepares submissions to the FDA in CTD or eCOPY format, conducts quality reviews of all regulatory documents for submission and any data reports, ... prepares submissions to the FDA in CTD or eCOPY format, conducts quality reviews of all regulatory documents for submission and any data reports, and advises on… more
- West Pharmaceutical Services (Exton, PA)
- …for CE Marking, and technical packages. The Sr. Specialist ensures timely and high- quality execution of all regulatory deliverables. In addition, the Sr. ... Attention to detail with planning, time management and organizational skills + Regulatory compliance competency including Quality Systems + Experience with… more
- Takeda Pharmaceuticals (Boston, MA)
- …globally. This role involves guiding and mentoring a team of experts, driving regulatory data quality confidence, ensuring global system reach and adoption, and ... regulatory data governance and stewardship practices and ensure data quality assurance for authoritative regulatory data sources. Proactively drive data… more
- Naven Health (Nashville, TN)
- … Quality Department under the direction of the Senior Manager of Quality , Regulatory , & education. **Job Description:** **Job Responsibilities (listed in ... customers, our teammates, and the patients we serve. **Job Description Summary:** The Quality Assurance Chart Review Nurse is responsible for the review of assigned… more
- Abbott (Alameda, CA)
- …to identify, review and assess the impact of worldwide product manufacturing, quality , regulatory or safety issues that arise in complaint investigations, ... medicines. Our 114,000 colleagues serve people in more than 160 countries. **Product Quality Assurance Analyst II** **Working at Abbott** At Abbott, you can do work… more
- Candela Corporation (Marlborough, MA)
- …assessment, and potential improvement actions related feedback. . Jointly accountable with Quality System (QS) and Regulatory Affairs (RA) Leadership for ... with at least 12 years in a management/leadership role in quality / regulatory / compliance. . Working understanding of relevant global/regional medical device… more
- Cleveland Clinic (Weston, FL)
- … compliance, sustain continual survey readiness and advance the delivery of high- quality care. You'll monitor regulatory outcomes, identify opportunities for ... formulate a response to survey activity findings and to quality of care/clinical inquiries from regulatory agencies....and to quality of care/clinical inquiries from regulatory agencies. + Ensure accreditation rounding data is trended… more
- Danaher Corporation (Miami, FL)
- …plus if you also possess previous experience in: . Prior internship or coursework in regulatory affairs or quality assurance . Understanding of FDA, EMA, or ICH ... career. Learn about the Danaher Business System which makes everything possible. The Regulatory Affairs Intern will gain hands-on experienc e in regulatory … more
- West Pharmaceutical Services (Exton, PA)
- … requests. With minimal support, the Sr. Specialist ensures timely and high- quality execution of all regulatory deliverables and ensures compliance with ... Sr. Specialist, Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date:...all times + Able to comply with the company's quality policy at all times + Able to work… more