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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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You will lead a program focused on managing third party providers, import duty expense, customs classification, maintaining good standing and participation in programs with U.S. Customs and Border Protection, ensuring all U.S. and Canadian import compliance regulatory requirements are met and fostering a culture of integrity and ethical conduct throughout the organization.
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Collaborate effectively in a matrixed environment with Medical Affairs, Creative/CRM/Digital agencies, Media, Market Research, Analytics, Business Technology Solutions (BTS), Field Operations, and Medical/Regulatory/Compliance/Legal integrated business partners.
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Applies extensive techno-functional experience to provide expert analysis, research and design of technical solutions that realize strategic benefits and enhance key business capabilities: Demand Planning and Forecasting; Supply Planning and Inventory Optimization; Network Optimization; Sales and Operations Planning; Procurement and Supplier Management; Inbound Logistics and Transportation; Traceability, Recall and Regulatory Compliance Management.
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Your teamAs a Principal Engineer at Baxter, you will provide Sterility Assurance leadership and technical support to multi-disciplinary product development teams, domestic/international manufacturing facilities, Regulatory Affairs and internal Sterility Assurance customers.
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QUALIFICATIONSEducationBachelors Degree (± 16 years)In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields are preferred or an equivalent combination of education and work experienceMasters Degree (± 18 years)PreferredDoctorate Degree (± 19 years) PreferredExperience/BackgroundMinimum 10 years Progressive work experience in regulatory affairs or a related discipline in the medical device field.
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General Functions, Specific Responsibilities, and Authority:The Senior Quality Engineer works closely with shared functions (e.g. Regulatory Affairs, Designated Complaint Handling Unit (DCHU), Sterility Assurance, etc.
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At the FBI you will have the opportunity to channel your knowledge of criminal law, constitutional law, or regulatory compliance to impact public corruption, organized crime, civil rights, and more.
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The primary focus of this role includes proofreading and light editing for brand communications, public affairs, and business writing. Proofreader/ Copy EditorContract Duration Months Job Summary: The Proofreader/ Copy Editor helps instill corporate brand through quality assurance of content for internal and external marketing communications across digital and print applications.
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The RN Coordinator ensures the residents of Bickford receive superior quality care, Bickford’s processes are followed and maintains regulatory compliance. Bickford Senior Living offers a comprehensive benefits plan to eligible team members including health, dental, vision, retirement benefits, short-term disability, long-term disability, and paid time off.
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Knowledge of and experience in working with regulatory agencies and funding sources, including DHS, DRS and CARF standards preferred. Ensures that policy, procedures and practices are in full compliance with all regulatory and accreditation agencies.
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Assist in implementing quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules and guidelines), and ensure compliance with testing SOPs and specifications. Must know operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical and medical device manufacturing labs.
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The Medical Assistant reflects the mission, vision, and values of Northwestern Medicine, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
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Regulatory Compliance: Ensure that all labeling processes adhere to Good Manufacturing Practices (GMP) and other relevant pharmaceutical regulations. A bit about us:With over 115 years of experience, our company specializes in providing printed cartons, labels, inserts, and flexible packaging to over 400 customers in various markets, including healthcare, natural health, personal care, and consumer goods.
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Job Title: Regulatory Affairs Associate I. This individual is recognized as a knowledgeable expert in regulatory affairs submission management. The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams.
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regulatory affairs jobs Title: intern Company: Medxcel in Green Oaks, IL
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