- Fujifilm (Austin, TX)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...other applicable laws. + Keep abreast of legislative and regulatory changes with respect to healthcare and other relevant… more
- Abbott (Plano, TX)
- … device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that... regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry. + 3-5+… more
- Astrix Technology (Fort Worth, TX)
- …EC Certificates (MDD /MDR) and associated documentation. **Key Requirements:** + 4+ years in medical device regulatory affairs + Experience with European MDR ... leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses...Supporting EU MDR compliance and lifecycle change management for medical devices. + Works closely with site regulatory… more
- Edwards Lifesciences (Dallas, TX)
- …pathology and physiology or Business Unit area of expertise + Moderate understanding of medical device regulatory requirements and documents, device ... + Knowledge of cardiovascular physiology and structural heart anatomy + Previous medical device Clinical Research experience in cardiology + Clinical research… more
- Stryker (Flower Mound, TX)
- …May serve as Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulation + May take responsibility for handling regulatory ... requirements, including ISO, FDA, and International requirements (ie, Medical Device Regulation) + Demonstrated expertise in regulatory systems in a… more
- Astrix Technology (San Antonio, TX)
- ** Medical Device QC Manager** Manufacturing San Antonio, TX, US Pay Rate Low: 85000.00 | Pay Rate High: 100000.00 + Added - 21/08/2025 Apply for Job _Our QC ... Chemistry, etc) + 2+ years of QC Supervisory/Managerial experience + GMP experience ( Medical Device , pharmaceutical, Life Sciences) + ISO 13485, ISO 9001, 21… more
- Fujifilm (Austin, TX)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... of experience with a Master's degree. + Minimum 8 years of medical device industry experience in a clinical capacity (clinical demonstration and education) with… more
- Fujifilm (Austin, TX)
- …II + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... and other Key Operators in the use of Fujifilm's Medical Informatics. The Senior Clinical Consultant, MI - I...business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties… more
- Fujifilm (Austin, TX)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... go-live.. Lead PE's must have expert level knowledge in all areas of medical informatics, IT infrastructure design and deployment, medical imaging industry in… more
- Fujifilm (Austin, TX)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... Knowledge Base articles. + Maintains an expert working knowledge of current medical imaging products and related technologies. + Engineers must have the ability… more