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Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
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Communicate and collaborate effectively with Sales and Marketing, R&D, Regulatory Affairs, Quality Engineering, and Medical Affairs in completing clinical evaluation project-related deliverables.
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Support the Company’s general legal needs, including commercial and government contracts, advertising, regulatory compliance, international product distribution and litigation management. The Kinetic Group is a world leader in the design, manufacture, and distribution of small caliber ammunition under the iconic brands Remington, Federal Premium, CCI, Speer and Hevi-Shot. We have domestic ammunition manufacturing facilities in Minnesota, Idaho, Arkansas, and Oregon, and service law enforcement, government agencies and sporting enthusiasts throughout the world.
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JOB DESCRIPTION Job TitleSr. Manager- Regulatory AffairsJob DescriptionThe Senior Manager Regulatory Affairs will play a critical role within Philips’ Clinical Informatics organization by leading regulatory projects for Philips’ Disease Management Solution products, ensuring and maintaining global accurate regulatory strategy and market access, directly impacting the lives of patients around the world.
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Provides leadership in the clinical research department for clinical trials study activities including patient enrollment and assessments, data management, study material preparation, regulatory document preparation, and project coordination in accordance with research standard operating procedures, federal and state regulations, Institutional Review Board (IRB) requirements, and International Council on Harmonization Good Clinical Practice guidelines.
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We have immediate openings for the position " Regulatory Engineer" Experience with SolidWorks, Siemens NX, SAP, Unigraphics, OrCad or Altium desirable. Ability to turn electrical system schematics into wire harness designs.
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Ability to maintain currency with industry changes including applicable laws, rule amendments, regulatory expectations and trends, DTCC technical specifications and other industry-wide initiatives that may have a material impact on swap data reporting.
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Demonstrate skill in documentation that meets all regulatory and DBT-PTSD standards. Fully licensed as a clinical mental health professional in Minnesota (LCPC, LPC, LMFT, or LMHC) Ideally, this individual has had exposure to other trauma modalities such as EMDR, ART (accelerated resolution therapy), AIR (adaptive internal relational) Network, Prolonged Exposure, or Somatic Experiencing.
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Job Title: MDR - Principal Regulatory Affairs Specialist. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
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A General Manager is a leader in their community, an inspiration to the team and the embodiment of the Caribou purpose: To create day making experience that spark a chain reaction of GOOD. Demonstrates the DOING of an Assistant General Manager with ease, enthusiasm and excellence.
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What you will Bring: Juris Doctorate degree from an accredited Law SchoolActive license to practice law, with either admission to the bar of the State of Minnesota or a limited in-house counsel license to practice law in the State of Minnesota 4+ years of in-house, law firm and/or regulatory agency experience in the areas of ethics and compliance.
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The role requires close collaboration with R&D, marketing, sales, regulatory, Medical/Clinical/Scientific Affairs, Legal and other cross-functional teams to ensure the products meet customer needs and regulatory requirements while driving business growth.
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Familiarity with inventory control, OSHA, HACCP and other regulatory requirements. Regularly inspect facility for safety hazards and either resolve them or report them to the safety manager as appropriate.
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The Regulatory Affairs Specialist will develop strategies, submissions, and regulatory reviews of medical device marketing materials for Teleflex Medical’s Interventional Urology business Unit. Submissions will be globally based for our medical device products and include devices in interventional urology products.
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GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. Responsibilities: Install, maintain, and repair fire alarm systems, electronic security systems, and CCTV systems.
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regulatory affairs jobs Title: affairs manager Company: Gpac in Osseo, MN
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