- 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
- Chemours (Austin, TX)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… 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
- Canon USA & Affiliates (Austin, TX)
- …Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum ... ** Regulatory Affairs Specialist - Post Market - req1434**...$72,000 to max $116,100 (annual equivalency) **_About us!_** _Canon Medical Systems USA, Inc., a world leader in diagnostic… more
- Bio-Techne (Austin, TX)
- …global regulatory strategies, ensuring compliance with FDA and international medical device regulations. Monitor industry trends, analyze regulatory ... manage workload independently. + Applied knowledge of FDA and international medical device regulations, global regulatory strategy, and submission processes.… 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
- 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)
- …I. + 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 resource will assist with the development...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 ... Knowledge Base articles. + Maintains an expert working knowledge of current medical imaging products and related technologies. + Engineers must have the ability… more