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This position will provide business partnering support to the technical functions within the Diagnostic Solutions Business Unit. This includes VP of R&D, VP of Medical Affairs, VP of Regulatory Affairs and VP of Business Process Excellence and their teams within the BU under the Life Science segment.
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Provide scientific and clinical expertise to internal (marketing, sales, regulatory affairs, R&D, and legal) and external (healthcare professionals, patients, advocacy groups, etc.) Supports the development of training materials, information technology systems and other scientific affairs infrastructure.
$200ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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What We Do Transamerica is organized by lines of business (Life Insurance, Annuities, Mutual Funds, Retirement Plans, and Employee Benefits), which are supported by Transamerica Corporate (Corporate Development; Finance; Internal Audit; Legislative, Regulatory & Policy; Office of the CEO; People and Places; Brand; Corporate Affairs; Risk; and Technology.
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Requires experience in clinical research and regulatory affairs including FDA regulated trials (IND/IDE). Requires experience in clinical research and regulatory affairs. Manage and monitor adherence to local, state, federal entities, GCP, IRB and other applicable regulatory requirements for study team and satellite sites.
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The Regulatory Affairs Manager position is responsible for the preparation of regulatory submissions required to market in vitro diagnostic devices in both domestic and international markets.
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Provides direction and support for Corporate Compliance, including acting as a consultant to the Legal/Sales/Government Affairs/Compliance/Executive Inquiry Teams. Knowledge of NCQA requirements of utilization review, Case Management standards and guidelines, appeal rights and responsibilities, and Regulatory requirements at the state and federal level for health care administration and Carrier standards.
$150Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Leads internal/external audit efforts for Federal and State Regulatory agencies and external Accreditation agencies as it relates to the specific programs within the Division. Ensures that delegated vendor partners are performing as required, in compliance with State and Federal regulatory requirements and accreditation agencies, to ensure members can access the benefits they are entitled to.
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Additionally, the Senior Director is responsible for directing the strategy for the Medical Science Liaison team and other members of the HQ PN Medical Affairs to ensure appropriate evidence generation and communication plans with healthcare professionals.
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5+ years of experience in quality assurance, compliance management, or regulatory affairs, preferably in a technology or manufacturing industry. Manage global regulatory compliance, testing, and accreditation management.
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Minimum of 10 years’ experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (FDA and/or EMA) and FDA REMS. College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred.
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Internally, EPRO works with the Office of Strategic Operations and Regulatory Affairs (OSORA) regarding CMS essential records management. Graduate degree with a major or concentration in Business Continuity or a related field or holding a current Certified Business Continuity Professional (CBCP)® or Master Business Continuity Professional (MBCP)® or Certified Public Sector Continuity Professional (CPSCP)® credential from the Disaster Recovery International Institute (DRII) may substitute for two years of experience.
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Department members continually work with senior members of Regulatory and External Affairs, Finance, Accounting and outside consultants in performing daily responsibilities and supporting strategic initiatives.
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The Vice President for Federal Affairs will work to position the Network as a trusted information source regarding market development, supply chain development, and technological advancement before policymakers and stakeholders, and forge strategic partnerships to advance critical policy or regulatory updates.
$100,000 - $120,000 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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We provide a complete turnkey service managing environmental affairs involving emergency spill response, remediation, regulatory reporting, and waste management. Performs periodic field investigations as needed to build and maintain necessary databases to verify regulatory compliance.
Full-timeRemoteExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Direct and supervise lobbying efforts to advance legislative and regulatory objectives and protect company's interests from adverse public policy. Reporting to the SVP of Government Affairs, this person would protect and promote Synchrony before the federal government and assigned state governments, while building coalitions and working with allies nationwide.
$150,000 - $250,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
regulatory affairs jobs in Rosedale, MD
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