- Chobani (New York, NY)
- …standards for food equipment sanitation, UL/ETL electrical safety requirements, and FDA food contact surface regulations Equipment Design and Analysis: Create ... Design heating, cooling, and temperature control systems for optimal beverage quality and food safety compliance Materials Selection: Specify appropriate materials… more
- Oracle (Little Rock, AR)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- Stanford University (Stanford, CA)
- …+ Experience executing randomized controlled trial treatment studies. + Experience with FDA regulatory procedures and reporting. + Demonstrated experience with ... conduct impactful clinical research with a focus on high quality and efficiency. We are seeking candidates with excellent...regulatory filing. Ensure compliance with HIPAA, GCP, and FDA regulations as applicable. + Own operational readiness for… more
- Oracle (Helena, MT)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- US Tech Solutions (San Bruno, CA)
- …Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA , Notified Bodies, etc.), and regulatory ... History File, and align with stakeholders. + Collaborate with Quality , Regulatory , Engineering, and UX teams to...Experience with medical device development standards eg ISO 13485, FDA 21 CFR 820 + Experience working with products… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …developing and executing the global GxP training strategy to ensure compliance with regulatory requirements and foster a strong quality culture across the ... lead the global GxP training strategy aligned with corporate quality objectives and regulatory standards. + Establish...training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance &… more
- Bausch + Lomb (Clearwater, FL)
- …environmental monitoring programs, and sterilization processes to ensure compliance with regulatory requirements, company quality standards, and industry best ... microbiological risk assessments for laboratory operations, ensuring alignment with corporate quality , safety, and regulatory requirements. + Review trend… more
- Cedars-Sinai (Los Angeles, CA)
- …pediatric populations preferred. + Experience with clinical trial budgeting and regulatory for FDA -regulated therapeutics preferred. **About Us** Cedars-Sinai is ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties & Responsibilities** +… more
- ITW (Burlington, MA)
- …in process and final inspection of products and components used in NRC/ FDA regulated environment. **Primary Responsibilities** + Mechanical inspection + Tensile and ... and acceptance criteria + Assists with testing of product to demonstrate regulatory compliance + Assist with investigating problems and recommending / implementing… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …measures to improve production methods, equipment performance, facility layout, and quality of product. 17. Provide scientific and/or technical advice and counsel ... regarding projects as needed. 18. Maintain current knowledge of regulatory and industry standards. 19. Generate thorough written reports, when required, that… more