- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles and CPV. ... + Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). + Excellent communication, collaboration, and influencing skills. + Ability to work effectively in a fast-paced, virtual environment. **Travel… more
- Wolters Kluwer (Coppell, TX)
- …regulatory published drug information and policy data sources (CMS, FDA , etc.) covering drug control/compliance programs, covered programs (Medicare/Medicaid) and ... other government drug-related policy and program information. * Have an in-depth understanding of drug classification systems, drug packaging attributes, drug clinical attributes, pricing and reimbursement data, and regulatory classifications-and how these… more
- US Tech Solutions (Waco, TX)
- …of Health, and legislative requirements including, but not limited to: the FDA , European Community (EC), ISO 13485 - Medical Devices, European Economic Community ... Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA. Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our… more
- Deloitte (Dallas, TX)
- …familiarity with ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, ... NDA, BLA, MAA) + 1+ years experience leading, managing and delivering complex engagements with resources in multiple locations + Bachelor's Degree + Ability to travel up to 50% on average, based on the work you do and the clients and industries/sectors you… more
- Boehringer Ingelheim (San Antonio, TX)
- …Performs all Company business in accordance with all regulations (eg, EEO, FDA , etc.) and Company policy and procedures. + Immediately reports noted/observed ... violations to management. + Demonstrates high ethical and professional standards with all business contacts to maintain BIVI's excellent reputation within the animal health community and internally. **Requirements** + Veterinary degree (DVM, VMD or BVSc)… more
- Texas Health Resources (Fort Worth, TX)
- …of Health, American College of Health, American College of Radiology, and FDA /MQSA guidelines. **Patient Safety:** . Verify patient with two identifiers. . Maintain ... equipment-clean and inspect, report any malfunctions. . Respond to emergency situations appropriately. **Additional perks of being a Texas Health CT Technologist:** . You'll enjoy top-notch benefits including 401(k) Plan, Employee Assistance Program (EAP), and… more
- Fujifilm (Austin, TX)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications:** Baseline Qualifications: + Bachelor's Degree, Trade School Certification (Industry related), or Industry Experience Equivalent + One or more industry-specific certifications in relevant… more
- Houston Methodist (Houston, TX)
- …conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research ... protocols and $70.3 million in extramurally funded translational research programs. Houston Methodist is an Equal Opportunity Employer. more
- Abbott (Austin, TX)
- …advanced degree. - Experience in medical devices, digital health, or FDA -regulated environments. - Familiarity with digital health technologies, and AI/ML ... applications. - Experience with data-driven decision-making and innovation strategy. - Willingness to travel up to 25%. The base pay for this position is $127,300.00 - $254,700.00. In specific locations, the pay range may vary from the range posted. An Equal… more
- BioLife Plasma Services (Austin, TX)
- …wear **Preferred Qualifications** + Familiarity with SOPs, GDP, GMP, CLIA, and FDA regulations + Experience working in a regulated industry or high-compliance ... environment **We Offer Comprehensive Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company-paid holidays + Tuition reimbursement + Retirement… more