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The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
$99,361 - $136,621 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report-out to management of major regulatory changes and issues of mock or real survey results.
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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POSITION OVERVIEW: The Regulatory Affairs, Accreditation & Safety Specialist (RASS) provides regulatory and safety expertise as related to Joint Commission, CMS, Oregon Health Authority, Pharmacy Board, OSHA, and other regulatory agencies.
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TITLE: Regulatory Affairs, Accreditation & Safety Specialist. Works with the Regulatory Affairs, Accreditation & Safety Manager to convene various QI and Safety committees and work groups, set agenda to drive desired meeting outcomes (based on contract and accreditation requirements), and ensure proper recording of committee activities.
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The Regulatory Science Policy Specialist will set strategy and oversee policy, scientific, and outreach activities related to the reduction and replacement of animal tests required or conducted by regulatory agencies and companies.
$71,821 - $92,856 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In the position of Regulatory Program Director in Roche / Genentech Pharma Technical Regulatory (PTR), you will be accountable for Health Authority interactions pertaining to CMC Information (i.e.: CMC information in an IND, IMPD and NDA/BLA/MAA filings), as well as informational and pre-submission meetings with global Health Authorities, partners and industry experts.
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Position Overview Reporting to the Senior Manager of Medicare Regulatory Compliance, the Medicare Regulatory Compliance Specialist will support the oversight and management of the Medicare Compliance Program.
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Serves as a coach, facilitator, and resource for patient safety initiatives and regulatory program activities. Knowledge of safety/risk management and regulatory accreditation/survey processes relating to health care organizations.
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The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports. The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings.
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Network Regulatory Specialist, reviews and regulatory construction documentation to ensure requirements have been met at the State and Federal level. Manage various network deployment projects and project phases: regulatory construction implementation (review regulatory docs: CDs, Station Records, FAA, FCC Filings, NEPA/NHPA reports) Review documentation for accuracy and quality to ensure a timely completion all regulatory filings.
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Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
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Providing overall leadership and direction to the Quality Assurance and Regulatory Affairs McKesson 3PL Team. The Senior Director, QARA is principally responsible for the development and implementation of the Company’s quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping Third Party Logistics VP of Quality Assurance & Regulatory Affairs informed on quality assurance and regulatory affairs matters.
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Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs. Partner with the CCO.
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Solid knowledge of the KYC and AML Compliance policies and how they are applied in a U.S. banking regulatory environment. Perform Client Due Diligence review in support of the Firm's new client onboarding and existing client regular review in accordance with the applicable regulatory program requirements (such as US, UK, Germany, Dubai, US, Hong Kong, Singapore KYC requirements and applicable eligibility standards.
$51,000 - $85,000 a yearFull-timeExpandApply NowActive JobUpdated Today
Title: regulatory specialist Company: Nevro
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