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Use stand-up reach forklift to move products, equipment, and materials while following all regulatory and company safety standards, policies, and procedures. Use stand-up reach forklift to move products, equipment, and materials while following all regulatory and company safety standards, policies, and procedures.
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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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Conduct investigative review and analysis in support of company’s BSA/AML regulatory compliance policies and program including investigating automated alerts from our transaction monitoring systems, and referrals sourced from law enforcement requests and other company lines of business.
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The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRCMC) Devices and Combination Products will be responsible for leading, developing, and implementing global CMC regulatory strategy related to Alexion’s drug/device portfolio, in vitro diagnostics and clinical decision software leading to successful registration and life-cycle management of unique and technologically complex products.
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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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Referral Bonus $1,000As a Forklift Operator, you will use stand-up reach forklift to move products, equipment, and materials while following all regulatory and company safety standards, policies, and procedures.
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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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Senior Regulatory Affairs Specialist. 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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Works closely, collaboratively and seamlessly with peer communications professionals supporting the state including Customer Communications Manager, the Internal Communications Manager, the Director of Communications and External Affairs, the Customer Service Center Communications Manager and the entire Corporate Communications team in corporate to ensure communication integration and maximum effectiveness.
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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards, as well as Bridgewell policies and procedures.
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Provide ongoing support to project teams for regulatory issues and questions. Interact and negotiate with regulatory agencies on defined matters as needed. Assist in the maintenance and improvement of regulatory SOPs.
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Be energized by joining a world-class company and regulatory team. Strong communication and regulatory writing skills. 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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Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. Abiomed's "Patients First!" Remote work options may be considered on a case-by-case basis and if approved by the Company.
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Ability to comprehend principles of engineering, physiology and medical device use. Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDA.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Amgen
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