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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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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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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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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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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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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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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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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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Regulatory affairs experience in the medical device industry with a track record of successful submissions. Provide ongoing support to project teams for regulatory issues and questions.
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Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance. 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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Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance. Provide support for changes to existing products, including providing regulatory assessment of changes, and subsequent regulatory filings.
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Interact and negotiate with regulatory agencies on defined matters as needed. Assist in the maintenance and improvement of regulatory SOPs. Be energized by joining a world-class company and regulatory team.
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Strong communication and regulatory writing skills. Ability to drive to completion in adherence to aggressive project schedules. Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Jobget
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