- 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
- 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...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
- Abbott (Austin, TX)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... challenging process engineering problems within Sterilization on diverse scope specific to medical devices . Independently leads the design and develops equipment… more
- Cardinal Health (Austin, TX)
- …regulation) preferred * Experience in private practice strongly preferred * Familiarly with medical device and pharmaceutical regulation * Active license in good ... **_What Regulatory contributes to Cardinal Health_** Legal provides the...regulations; and other product-specific environmental / sustainability drug and device lifecycle obligations and stewardship programs. This role will… more
- Grifols Shared Services North America, Inc (Fort Worth, TX)
- …regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides ... submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
- United Therapeutics (Austin, TX)
- …), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee… more
- Houston Methodist (Houston, TX)
- …within an academic research environment or FDA regulated industry + Experience in medical devices , diagnostics, or pharmaceuticals and/or within an academic ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating...of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and… more