- Teva Pharmaceuticals (Parsippany, NJ)
- …Lead, Clinical Scientist. and other functional areas such as GCO, biostats, regulatory , pharmacovigilance. The Director will be a key contributor to INDs, NDAs, ... BLAs, and other global regulatory filings and publications. The Director will foster relationships...during clinical trial conduct to identify trends and ensure quality data for database locks and interim cuts. +… more
- Abbott (San Diego, CA)
- … compliance. + Collaborate closely with cross-functional teams including Regulatory Affairs, Quality Assurance, Biostatistics, and Program Management. ... in-vitro diagnostics for 510(k) OTC and dual 510(k) and CLIA waiver regulatory pathways. They will work closely with cross-functional teams and participating on… more
- Access Dubuque (Dubuque, IA)
- …service leaders. Provides leadership for regional efforts to assure compliance to regulatory agency standards and continuously improve the quality and safety ... throughout the region. Works closely with the Director of Quality , Chief Nursing Officer and the UnityPoint Health system...organizations such as DNV, OSHA, Food and Drug Administration ( FDA ), etc. + Manages regulatory agency survey… more
- UnityPoint Health (Dubuque, IA)
- …service leaders. Provides leadership for regional efforts to assure compliance to regulatory agency standards and continuously improve the quality and safety ... throughout the region. Works closely with the Director of Quality , Chief Nursing Officer and the UnityPoint Health system...organizations such as DNV, OSHA, Food and Drug Administration ( FDA ), etc. + Manages regulatory agency survey… more
- Takeda Pharmaceuticals (Boston, MA)
- …to track value delivery.** **_ACCOUNTABILITIES:_** + **Drive platform rationalization, data quality , and master data management strategies across Regulatory and ... projects ensuring delivery on time, within budget, and to quality standards. + Ensure all systems meet regulatory... requirements (21 CFR Part 11, GAMP 5, GDPR, FDA /EMA guidelines). + Manage and mentor a team of… more
- Penn Medicine (Philadelphia, PA)
- …execution of day-to-day operations for the department. Ensures consistent delivery of high- quality patient care and services as a trusted advisor to the department ... and innovative for patient needs. DOO ensures compliance with regulatory bodies. **Responsibilities:** Department Strategic Planning & Change Management: +… more
- Teleflex (Wyomissing, PA)
- …Experience with documentation, method optimization, and cross-functional collaboration. * Familiarity with regulatory and quality frameworks (eg, FDA 21 CFR ... method development, and medical device evaluation, ensuring compliance with protocols, quality systems, and regulatory requirements. * Prepare, optimize, and… more
- Penn Medicine (Philadelphia, PA)
- …section Performs teaching functions with residents and Medical Laboratory Science Students. Regulatory Compliance: Works with the Division's Quality Assurance ... section Assumes overall responsibility for the formulation and monitoring of a Quality Control/ Quality Improvement program Takes responsibility for staff errors… more
- Guidehouse (Mclean, VA)
- …immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing ... immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing… more
- Abbott (Burlington, MA)
- … system improvement activities. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and Abbott policies, ... Burlington, MA location in the Abbott Heart Failure Division Global Design Quality Department. In Abbott's Heart Failure (HF) business, we're developing solutions to… more