- Seattle Children's (Seattle, WA)
- …strategic direction and leadership to the Seattle Children's Research Institute in quality analysis and regulatory support for clinical research. Leads overall ... for our patients and families. Responsible for establishing and maintaining a quality assurance and regulatory support program throughout the research… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... a digital-native leader responsible for shaping, coordinating, and managing regulatory activities across the Digital Unit (DU). The DU...+ Act as an effective business partner, by driving quality mindset to reinforce the corporate brand and become… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports regulatory… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... . **Job Description** This role is responsible for coordinating and managing regulatory activities across the Digital Unit (DU). The Digital Unit is a… more
- Battelle Memorial Institute (Columbus, OH)
- …procedures are being followed. + Interprets and applies existing and new regulatory requirements and industry standards to operation methods and practices. Reviews ... be compliant and will withstand external audit. + Develops and executes quality assurance plans, applying appropriate measures, metrics, and management controls with… more
- ITG Brands (Greensboro, NC)
- …requests and responses, including strategy, redactions, and risk mitigation. Partner with Quality and Regulatory Affairs teams to support consumer complaint ... Senior Regulatory Counsel **Location** North Carolina **City** Greensboro **Role...+ We are seeking a seasoned and strategic Senior Regulatory Counsel to join our Legal and Regultaory team.… more
- Parexel (Trenton, NJ)
- …Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control. + Utilize regulatory /product knowledge to provide operational ... especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality . Exceptional candidates with 3+… more
- Merck & Co. (Durham, NC)
- …manufacturing excellence from development through commercialization. You'll partner across Quality , Regulatory , Technical, and Supply Chain teams-coaching, ... Partnerships, Program Management, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance, Risk Management, Stakeholder ManagementPreferred… more
- Endo International (St. Louis, MO)
- …ensure that all manufacturing, testing, packaging, storage, and distribution activities meet regulatory standards and deliver the highest product quality . The ... + Minimum of 15 years of pharmacuetical industry experience in a Quality Assurance and/or Regulatory Affairs function including experience in manufacturing… more
- Insmed Incorporated (NJ)
- …internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, ... supporting biologics, drug products, or combination products.Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts 210/211,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …project teams, Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs, etc. + Independent organizational and time ... by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) more
- Olympus Corporation of the Americas (Westborough, MA)
- …and Training. + Minimum of 7 years experience managing the business aspects of quality and regulatory projects. + Good analytical toolkit. + Ability to influence ... by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) more
- Cordis (Miami Lakes, FL)
- … Quality Management System (QMS), customer requirements, and applicable regulatory standards. This leadership role provides guidance, training, and support to ... behind the people who keep saving lives. **Responsibilities** **Job Summary** The Quality Inspector Supervisor is responsible for overseeing the daily activities of… more
- Cordis (Irvine, CA)
- …finished products) at every stage of the process, ensuring compliance with regulatory standards and internal quality requirements. + Process Improvement: ... that address unmet and critical medical needs. **Responsibilities** The Quality Engineer will be responsible for ensuring that our...ensure the safety and efficacy of medical devices. + Regulatory Compliance: Stay up to date with regulatory… more
- Cordis (Irvine, CA)
- …solutions that address unmet and critical medical needs. **Responsibilities** The **Senior Quality Engineer** joining the Quality team, will be responsible for ... ensuring that our medical devices meet the highest quality standards throughout the manufacturing process. You will be...ensure the safety and efficacy of medical devices. + Regulatory Compliance: Stay up to date with regulatory… more
- Cordis (Irvine, CA)
- …global regulatory standards and to champion a culture of quality excellence throughout the organization. **Key Responsibilities** + Lead and coordinate change ... that address unmet and critical medical needs. **Responsibilities** The Quality Program Manager oversees and manages quality ...The Quality Program Manager oversees and manages quality programs, initiatives, and the Quality Management… more
- BeOne Medicines (San Mateo, CA)
- …expectations. This role provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs, Quality , Safety/Pharmacovigilance, ... data in the BRIM system. + Monitor data quality , integrity, and completeness of regulatory records,...Monitor data quality , integrity, and completeness of regulatory records, including submissions, HAQs, commitments, and global … more
- WK Kellogg Co (Battle Creek, MI)
- …in quality operations, sanitation, food safety, materials management, innovation quality , regulatory , leadership, and business acumen. + Demonstrated problem ... join us in this effort. Are you passionate about quality and food safety? It's at the heart of...(PDCA) cycle. Provide oversight to compliance against company and regulatory standards and requirements. + Technical Guidance - You… more
- SMBC (New York, NY)
- …Regulatory Relations data including KPIs and CSI related information. + Providing quality assurance and monitoring Regulatory Relations KPI. + Enhancing ... a competitive portfolio of benefits to its employees. **Role Description** The Regulatory Relations and Public Policy Group ("RRPP") is dedicated to managing… more
- Integra LifeSciences (Braintree, MA)
- …A minimum of 2-4 years' experience in a medical device, pharmaceuticals, Quality / Regulatory Compliance, or other cGMP regulated product preferred environment. + ... outcomes and set new standards of care. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** The Quality Control Technician II will be responsible for performing quality … more
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