- Fujifilm (Austin, TX)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... the product sales, product marketing at a Healthcare / Medical Imaging / IT organization. + Broad functional experience...against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- Fujifilm (Austin, TX)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally...as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… 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)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… 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
- Stryker (Flower Mound, TX)
- …a related field + 6+ years of experience in a regulated environment ( Medical Device , Pharmaceutical, Biomedical, or Automotive). + Experience leading and ... **Senior Project Manager, International Regulatory Affairs** _San Jose, CA / Flower Mound,...skills, experience, and other relevant factors. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance,… more
- Abbott (Plano, TX)
- …of product complaints; Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for ... entry of complaints in database. Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory… more
- Cordis (Houston, TX)
- …treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, ... SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions. At Cordis, we're teammates, not just employees. We embrace an… more
- Bausch + Lomb (Austin, TX)
- …departments (eg, R&D/Project Management, Clinical/ Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device ... areas to provide input on study-related documents and issues (DMP, SAP, drug/ device supplies, CSR, etc.). + Provides clinical operations input in the identification,… more
- Edwards Lifesciences (Austin, TX)
- …**_Note: this Clinical Specialist will support field cases for PASCAL (mitral valve device ) in the local region, along coverage where needed across the US_** **_. ... ideal._** **How you will make an impact:** + Educate physicians on device handling, implantation and troubleshooting techniques related to the equipment required for… more
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