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They will interface with other Insulet departments (e.g., varying levels of Management, Systems Engineering, Software Engineering, Design Verification and Regulatory Affairs) as well as other functional teams on initiatives related to product development and lifecycle/sustaining project support.
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Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
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Regulatory Affairs Specialist 1 needed for a one year W2 contract for a Bio Manufacturing Company in Hercules, CA. Interface daily with desktop publisher, technical writers and Regulatory Affairs Specialists.
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Direct experience in a Quality or Regulatory Affairs role in a GMP related industry. The primary function of the Quality Specialist is to assist in maintaining the quality system.
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PhD or MS in analytical or organic chemistry and 7+ years relevant experience preferably in analytical chemistry, API development and scale up/manufacturing, or at least 7+ years leadership position to enforce cGMP compliance and regulatory affairs.
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Responsible for the regulatory proof section of the packaging design process via the PLM software platform. 2-3 years' experience within food or consumer packaged goods labeling and regulatory.
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Job Summary: Under the direction of the Manager, Regulatory Affairs & Compliance, the Regulatory Compliance Specialist supports the compliance program by coordinating implementation of new and revised healthcare rules and requirements as are communicated by state agencies.
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Experience in compliance, quality, accreditation, government affairs/lobbying a plus. Reviews Provider Agreement, EOC/ Member Handbook, Provider Directory, marketing materials, and other contract reporting deliverables for compliance with contractual and regulatory requirements prior to submission.
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Previous Quality Assurance/Quality Control/Regulatory Affairs experience. Certified Tissue Bank Specialist (CTBS) certification within 2 years of hire. Knowledge of applicable regulatory requirements from AABB, AATB, FDA, OSHA & ISO.
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Researching and consolidating regulatory requirements to enable future development of regulatory strategies for all regions. · Complete Regulatory Corrective and Preventive Actions generated from audit findings.
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Full-time work experience related to pharmaceutical industry, supply chain management (distribution), regulatory affairs or equivalent education and experience. Title: Quality Specialist II.
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Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings. Monitors study team compliance with protocol and SOPs; submits all regulatory paperwork required; communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.
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Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience, typically with a quality, product-development/support, or scientific affairs function. Role: Regulatory Specialist II.
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Position SummaryThe Compliance Specialist III works directly with Director of Compliance within the area of Regulatory and Consumer Affairs. The Compliance Specialist III is required to be extremely knowledgeable and skilled in regulatory compliance matters.
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Reading, interpreting, and responding to Managed Care regulatory bodies and contracts. Molina Healthcare of Nevada is hiring for a Managed Care, Gov Contracts Sr. Specialist. The Sr. Specialist role will involve coordination of all Government Contracts deliverables, primary focus will be to improve and standardize priorities, initiatives.
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