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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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We’re seeking a Regulatory Affairs - Specialist Global Labeling Lead Medical Devices to work at a premier medical device company in Rochester, NY. With us, it’s all about finding the job that’s just right.
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Regulatory Affairs representative for theCT/AMI Systems and assists with regulatory issues related to such items as labeling and marketing ideas, claim development and prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for a program.
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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
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Regulatory Advice: Provide legal guidance and support to cross-functional teams, including Global Operations, Global Scientific & Regulatory Affairs, Government Affairs, R&D, marketing, quality assurance, and supply chain, to ensure product formulations and labeling comply with food laws and regulations.
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Primary Talent Partners has a 12 month contract opening for a Regulatory Affairs Specialist (MDR) with a Medical Device client of ours. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
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Job Description Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
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You will guide the business with respect to quality and regulatory affairs issues, complaint handling and initiatives to maximize the operational capacity of Oticon Medical's distribution of auditory implantable devices.
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Artwork Process Collaborate with Regulatory Affairs, approved vendors, and printers to create print ready artwork and proofs assuring proper layouts, artwork meets requirements for CMO needs and is compliant with current regulatory approvals, regulatory guidelines, and established component specifications.
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The Senior Regulatory Affairs Specialist supports product development as a core team member and is responsible for regulatory submissions and registrations. Job Title: Senior Regulatory Affairs Specialist.
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Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle.
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Serves as the internal subject matter expert for international regulatory affairs on assigned projects/regions, including labeling review. Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California page is loaded.
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Provide legal guidance and support on a wide range of regulatory and medical affairs matters, including but not limited to pre-market approvals, submissions and responses to the FDA, quality systems, commercialization, advertising, promotions, marketing, communications and labeling for on-label and off label products, new product introductions and revenue models, post-surveillance, inspections, deficiency/warning letters and/or recalls.
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Drive and project manage legal projects and conduct training to the regulatory, medical affairs, sales and marketing teams. Excellent communication skills and ability to collaborate with cross-functional teams and executives from regulatory, medical affairs, marketing, sales, support and their operational teams.
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The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
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