- Chemours (Austin, TX)
- …outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer ... Chemours chemistry. Chemours is seeking a Product Stewardship & Regulatory Expert - Medical Applications to join our growing Advanced Performance Materials (APM)… more
- 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
- Bio-Techne (Austin, TX)
- …global regulatory strategies, ensuring compliance with FDA and international medical device regulations. Monitor industry trends, analyze regulatory changes, ... to manage workload independently. + Applied knowledge of FDA and international medical device regulations, global regulatory strategy, and submission processes.… 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
- 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
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …+ **Compliance & Governance:** + Ensure all omnichannel activities adhere to internal medical , legal, and regulatory standards. + Collaborate with Compliance and ... Experience working within a matrixed environment. + Knowledge of pharmaceutical legal, regulatory , and medical processes. + Strong matrix team-building skills, a… more
- Edwards Lifesciences (Dallas, 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
- Canon USA & Affiliates (Austin, TX)
- …PC skills, including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum Education ... ** 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
- Sumitomo Pharma (Austin, TX)
- …call guides, SOPs, work instructions and training resources per the SMPA legal, medical , and regulatory approval process + Support development and regulatory ... work closely with key stakeholders including the Brand Franchise team, Finance, Regulatory , Legal, Supply Chain, and Manufacturing as well as critical HUB vendors.… more
- BrightSpring Health Services (Denton, TX)
- … medical records, of person(s) served in a manner consistent with medical , administrative, ethical, legal and regulatory requirements of the health services ... meetings as coordinated by Registered Nurse supervisor + Monitor triage reportsMaintain medical records according to are regulatory requirements + Maintain all… more