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As part of the Regulatory Affairs Asia Pacific (APAC) team, on-site at our Diabetes Care Division HQ location in Alameda, CA. As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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The Regulatory Affairs Specialist will be responsible for supporting regulatory strategy, conducting regulatory research, producing technical reports to support regulatory implementation or commercialization of new products and processes in the dental/orthodontic area.
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The Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. Regulatory Affairs Manager - Electrophysiology page is loaded.
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Overview: We are looking for an experienced Regulatory Affairs Manager to manage the entire Product Registration, including being the primary contact with all certification entities, regulatory agencies (including customs), and independent laboratories, including, but not limited to, WQA, NSF, IAPMO, and UL for Culligan Consumer Products Division.
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Responsibilities: The Snr Product Regulatory Specialist is responsible for obtaining registrations and certification approvals for new and existing products, necessary to sell them to worldwide markets.
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Intern will work closely with a cross-functional team on Clinical and Regulatory Affairs, with adjacent teams in IT, Operations, Project Management and Product Development. The Clinical and Regulatory Affairs team is looking to hire a summer intern.
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The Director of CMC Regulatory Affairs will oversee and support development CMC team activities for an emerging portfolio of small molecule programs in neuroscience. Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs supports a portfolio of small molecule development programs and marketed products across multiple locations and is committed to providing the best strategy through dedicated teamwork, professional excellence, and collaboration at every opportunity.
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The Director of Global Regulatory Affairs CMC is responsible for the development and execution of global Chemistry, Manufacturing, and Control (CMC) regulatory strategies that support the success of products throughout their lifecycle.
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A Regulatory Affairs/Safety Officer Specialist ensures compliance with all OSHA requirements, supports GMP compliance activities by participating in audits, preparing for regulatory inspections, reviewing procedures, and maintaining error-reporting systems.
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You've acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K's, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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The Director of Energy Policy and Government Affairs will be focused on the development and advancement of a legislative and regulatory policy framework that advances our energy storage, solar, and sustainability solutions offerings.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.
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Regulatory affairs experience in the medical device industry with a track record of successful submissions. Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.
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You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period.
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regulatory affairs jobs Title: intern Company: Medxcel Facilities Management
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