- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of ... + Contributing to the design, implementation and advancement of the Clinical and Safety Quality Compliance strategy, model, and operations as a key member of the… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …scenarios: + Other duties assigned by Leadership (Attend cross-functional meetings to represent Quality Compliance and present open items for which resolution is ... **Job Description Summary** Fulfill FDA , ISO and other relevant requirements for designated...understanding of Edwards policies, procedures, and guidelines relevant to quality compliance + Proficient knowledge of medical… more
- Actalent (Hadley, MA)
- …Collaborate with R&D and production teams to improve product quality . Maintain compliance with industry regulations such as FDA , GMP, and ISO. Document and ... documentation. + Collaborate with R&D and production teams to improve product quality . + Maintain compliance with industry regulations (eg, FDA , GMP, ISO). +… more
- Nissha Medical Technologies (Buffalo, NY)
- …DMRs (Device Master Records) and DHFs (Design History Files). + Regulatory & Quality Compliance : Ensure new product launches meet FDA 21 CFR Part 820 and ISO ... ensuring design transfer, validation, and manufacturing scale-up meet cost, quality , and timeline objectives while complying with FDA...CFR Part 820), ISO 13485, ISO 14971, and MDR/IVDR compliance . + Experience working with Class I, II, or… more
- RWJBarnabas Health (West Orange, NJ)
- …academic and industry partners. The successful candidate will bring deep expertise in FDA regulations, IRB processes, HIPAA compliance in research, and federal ... years of legal experience, including substantial experience with clinical research, FDA regulatory compliance , and research contracting + Comprehensive knowledge… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The ** Quality Compliance Specialist** will provide quality compliance ... Quality Management Reviews + Serve as the quality compliance representative for project teams +...and internal Standard Operating Procedures + Provide support in FDA inspections, ISO audits and customer audits at the… more
- Houston Methodist (Houston, TX)
- …and study specific processes under the direct supervision of the Regulatory Compliance Manager ** QUALITY /SAFETY ESSENTIAL FUNCTIONS** + Ensures compliance ... At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory… more
- Bausch + Lomb (Tampa, FL)
- …the advancement of eye health in the future. **Objectives/Purpose of Job:** The Quality Compliance Specialist is responsible for ensuring that the organizations ... Quality Management System (QMS) is compliant with applicable regulatory...and site standards such as but not limited to ( FDA , cGMP, ICH, etc.) and internal policies. This role… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Quality Compliance Specialist Department: Quality Location: Monroe, NC START YOUR APPLICATION ... POSITION SUMMARY: Under the direction of the Senior Manager, Quality Compliance , the Quality ...of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as they relate to… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. **Summary** The Senior Manager, Compliance and Quality Risk Management at RayzeBio serves as the Local ... and subject-matter expertise to site teams, promoting the adoption of Quality Risk Management (QRM) principles and building capability across the organization.… more