- Cordis (Irvine, CA)
- …Accountabilities** + Collaborate with cross-functional teams, including product management, regulatory affairs , quality assurance, and manufacturing, to define ... + Knowledge of medical device design principles, human factors engineering, and regulatory requirements (ISO 13485, FDA guidelines, etc.). + Proficiency in… more
- Novo Nordisk (Omaha, NE)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- University of Pennsylvania (Philadelphia, PA)
- …mission. Prepare draft PS-IDE applications for faculty review and submission to FDA . Draft components of clinical protocols and informed consents documents ... in collaboration with faculty. + Regulatory -Financial-Training/Continuing Education: Negotiate clinical trial agreements and...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- Genentech (South San Francisco, CA)
- …and ethical considerations in clinical research; Familiarity with global regulatory frameworks and global research expectations (eg, FDA , EMA, ICH). ... Science Strategy team, to translate insights into actionable recommendations that strengthen clinical trial design, medical plans, and regulatory strategy. The… more
- Takeda Pharmaceuticals (Boston, MA)
- …talent with the ability to make tough talent decisions. + Deep expertise in ** Regulatory Affairs , Clinical Development, and R&D technology ecosystems** (eg, ... role owns a portfolio of platforms and products-such as Regulatory Information Management (RIM), Clinical Operational, ... requirements (21 CFR Part 11, GAMP 5, GDPR, FDA /EMA guidelines). + Manage and mentor a team of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … colleagues) to develop and implement integrated strategies that align with the Medical Affairs goals while ensuring compliance with ACCME, FDA , OIG, and other ... needs. This position is essential for shaping the future landscape of clinical practice and research, ensuring robust education on guidelines-based care to improve… more
- Envista Holdings Corporation (Pomona, CA)
- …whether to accept the product and future purchases from the vendor. + Supports Regulatory Affairs with their activities related to submissions and notified body ... develop, implement, and maintain quality assurance protocols that comply with regulatory requirements and industry standards. The Sr. Quality Engineer will possess… more
- Abbott (Sylmar, CA)
- …from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Strong knowledge of defined development ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Genentech (South San Francisco, CA)
- …I-IV), medical writing, and data analysis, with a thorough understanding of US regulatory / FDA requirements. + Demonstrated ability to coach, mentor, and develop ... will manage a group of Medical Directors/Medical Science Directors, providing exceptional clinical , scientific, and people leadership. In USM, we focus on broadening… more
- Medtronic (Newton, MA)
- …enhance workflow and product knowledge. + Collaborate with cross-functional teams, including R&D, regulatory affairs , and clinical teams, to ensure alignment ... efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR,...a relevant field. + Certification in quality systems or regulatory affairs (eg, Six Sigma, ASQ, or… more