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Provide hands on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submissions. Perform regulatory submission/approval activities for specific complex ACIST Medical Systems products. Represent ACIST Regulatory with US and international regulators on submission reviews/app
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The Principal Regulatory Affairs Specialist will, in cooperation with the Vice President of Regulatory/Clinical, lead the development of international strategies within Regulatory Affairs that achieve longer term business goals. This role will provide strategy and infrastructure/process management support for ACIST international regulatory reimbursement and Quality Management System (QMS) submissi
Posted Today
Manage, in cooperation with the Vice President of Regulatory, the development of global strategies and organizational development initiatives within Regulatory Affairs that achieve longer term business goals. Provide strategy and infrastructure management support for ACIST US and EU regulatory and Quality Management System (QMS) submissions for ACIST Medical Systems product lines. Implement proces
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Design, develop, and document software applications embedded in diagnostic and interventional cardiology devices. Participate in all phases of the software lifecycle, including concept development, requirements, design, implementation, and testing. Primary Duties and Responsibilities Apply solid software design skills to develop medical devices to meet specific performance requirements and deliver
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The Scientist role is a strategic position within the Research and Technology (R&T) organization, reporting to Vice President of R&T of Bracco Medical Technology. This position will lead and oversee the research engineering function and work closely with other functional area partners and stakeholders. The Scientist plays a primary role in identifying and assessing novel medical technologies and t
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Participate in all aspects of the mechanical design of new electromechanical medical devices, accessories and consumables. Provide project leadership, specifications creation, perform engineering modeling and analyses, develop test methods and fixtures, document and communicate the design internally and to suppliers. Significant creativity and experience is essential, using engineering practices i
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Technically lead engineering teams through innovative design, development and deployment of the company’s medical device products that meet customer specifications and quality standards. Ensure alignment of product development strategy to business strategy in order to accelerate the development and commercialization of products to the market. As a member of the broader organizations technica
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Manage and lead product development projects ensuring consistency with corporate strategy, company policies, and regulations. Ensure product performance to customer/functional specifications is in balance with deadlines and budgets. This includes identifying resources and coordinating the efforts of cross functional project team members to deliver projects according to plan. Primary Duties and Res
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The Associate Product Manager, Portfolio Marketing is responsible for supporting the modality product portfolio management team with priority focus on developing programs and tools to drive product awareness, utilization and enhance customer engagement. This strategic marketing position requires an organized, confident, motivated, self starter that has the ability to take ideas from concept to dev
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This is a technical, hands on director role that leads the ACIST global operations engineering team. This position is responsible for enhancing operations engineering strategic direction, and ensuring work is performed in accordance to Quality Management System (QMS) and Regulatory Requirements. The director owns operations engineering responsibilities for new product development, sustaining and i
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The Talent Acquisition Specialist is responsible for attracting, sourcing and recruiting talent for the ACIST organization. This role will create multiple pipelines of active and passive candidates with various skill sets and experiences, drive and facilitate the internship and co op program and leverage employer branding to build awareness and engagement to attract talent to our organization. Pri
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Key contact in the Customer Support/Technical Services department for customer requests for after sales support and technical assistance, service and repair pertaining to the use and failure resolution of ACIST injectors (and associated products) installed within our customer base. This position routinely interacts with Customers (Cardiac Cath Lab, CT, MR Lab staff and Biomedical Engineers), Regio
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