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The Regulatory Affairs Specialist is expected to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory/compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site trials.
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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 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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Director of Risk Management & Regulatory Affairs ( Patient Safety Officer / Privacy Officer ) The Director of Risk Management and Regulatory Affairs (Patient Safety Officer/Privacy Officer) serves as an accessible resource to the hospital and community on risk management and regulatory issues.
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Collaborate with cross-functional teams and executives from regulatory, medical affairs, the business units, marketing, ethical compliance, sales, service, support and operations. 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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Join Our Crew Senior Manager, Technical Writer, Regulatory Affairs (Remote) Philadelphia, PA. The technical writer works with Quality and Regulatory personnel to ensure compliance with US, EU, and ICH requirements.
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6+ years of legal experience, including government, in-house and/or law firm experience advising technology companies, including demonstrated work experience in the area of trust & safety and regulatory affairs.
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Head development of a regulatory engagement plan in alignment with broader Company strategy and department implementation goals through regular discussions with other departments including Utility of the Future, Energy Policy and Regulatory Affairs, Customer Operations, AMI, Gas Engineering and Strategic Planning.
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Analytics Insights, Business, Business Direction, Client Relationship Management, Finance, Global Market, Marketing Strategies, Portfolio Management, Regulatory Compliance, Sales, Structured Products.
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Highly reputable, established, Fintech looking to appoint a Legal Counsel/ Financial Services Regulatory Counsel in NYC to expand their In-House legal and regulatory compliance capability/ team.
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Facilitates alternative forms (i.e., mediation, restorative justice) of dispute resolution, when appropriate, and consult with the Dean of Students, Title IX Coordinator, and legal counsel regarding complex higher education legal and regulatory issues.
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Under the direction of the Assistant General Counsel, Product and Regulatory, you will play an immediate and direct role as Senior Counsel leading coverage for the Circle Account and wide variety of digital asset products.
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Similar Jobs (5) Global Trade & Shopper Lead - Allegra locations 2 Locations time type Full time posted on Posted 30+ Days Ago Medical Safety Head, PV (CHC) locations 3 Locations time type Full time posted on Posted 30+ Days Ago US Regulatory Affairs Lead, OTC Brands locations Bridgewater, NJ time type Full time posted on Posted 3 Days Ago.
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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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regulatory affairs jobs Title: compliance Company: Circle
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