- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Astrix Technology (Fort Worth, TX)
- …Year contract position** + Supporting EU MDR compliance and lifecycle change management for medical devices. + Works closely with site regulatory teams to manage ... and associated documentation. **Key Requirements:** + 4+ years in medical device regulatory affairs + Experience with European MDR and manufacturing environments… more
- Molina Healthcare (San Antonio, TX)
- …+ Experience with Medicare, Medicaid and Marketplace is required. + Medical coding experience is highly preferred. **JOB QUALIFICATIONS** **Required Education** ... Bachelor's Degree or equivalent combination of education and experience **Required Experience** 7-9 years **Preferred Education** Graduate Degree or equivalent experience **Preferred Experience** 10+ years To all current Molina employees: If you are interested… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …medicine (T0 - T1) or early development (phase 1) assets either within Medical Affairs, Regulatory Affairs, or Clinical Development is preferred. + Minimum ... CNS disorders, we are seeking a skilled and experienced Medical Director of CNS Early Assets, Global Medical...and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay… more
- Sumitomo Pharma (Austin, TX)
- …communication + Ensure that development of launch materials/new claims with Marketing, Medical and Legal are guided by applicable regulatory requirements + ... requirements cross functionally through comprehensive education initiatives + Oversees Regulatory operation and medical writhing team as appropriately +… more
- Cardinal Health (Austin, TX)
- … medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs. **Responsibilities:** + Collaborate across multiple functions ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… 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 Marking ... 5-7+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical... regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry. + 3-5+ years of… more
- Edwards Lifesciences (Austin, TX)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... physiology or Business Unit area of expertise + Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse… more
- Stryker (Flower Mound, TX)
- …within associated division or business units + May serve as Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulation + May take ... regulatory requirements, including ISO, FDA, and International requirements (ie, Medical Device Regulation) + Demonstrated expertise in regulatory systems in… more
- Cardinal Health (Austin, TX)
- … affairs and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. More ... **_What Regulatory Submissions Operations contributes to Cardinal Health_** ...benefits and programs to support health and well-being. + Medical , dental and vision coverage + Paid time off… more