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Interest in healthcare administration, compliance, and regulatory affairs is preferred. Stay updated on industry trends, regulatory changes, and best practices related to compliance and credentialing in the healthcare sector.
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Reporting and Documentation: Prepares and submits U.S. Pre-Manufacturing Notifications (PMNs) and Canadian New Substance Notifications (NSN), along with regulatory reports such as Chemical Weapons reporting and TSCA Section 8.
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Regulatory Compliance Expertise: Advanced understanding of local, state, and federal regulations related to underground utilities, coupled with the ability to effectively incorporate these regulations into permit drawings, Advanced understanding of Telecom OSP Engineering and Construction standards to apply design standards to underground and aerial pole line cable plant, including Joint Use Design, Pole Replacement, Primary Service, and Reliability/Maintenance Design.
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Juris Doctor degree from an accredited School of Law, Admission to the NYS Bar, & 5 years of responsible experience in the practice of law following NYS Bar admission, in the fields of Healthcare Compliance, Regulatory Affairs, Risk and Quality Management and/or in similar areas; or.
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Serve as a key subject matter resource on healthcare laws and regulations, including, without limitation, monitoring of regulatory developments, and legal research on regulatory issues, including fraud and abuse issues, HIPAA compliance, EMTALA, Medicare and Medicaid compliance, licensure issues, pay-to-play issues, corporate governance and regulatory issues related to tax-exempt entities.
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These responsibilities involve working closely with Clinical Operations, Clinical Development, CMC, Medical Affairs, Regulatory Affairs, CROs, CDMOs, Clinical Trial Sites, and laboratories.
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This internship offers an excellent opportunity to gain hands-on experience in healthcare administration, compliance research, and professional communication within the industry, as well as future full-time employment as we grow.
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Reporting to the Director of Regulatory Affairs, the successful candidate will lead regulatory activities related to the development, submission, and approval of dermatology products in compliance with global regulations and standards.
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The Senior Regulatory Affairs Specialist will be responsible for performing a wide variety of tasks to. documents, product claims and labeling ensuring risk-based regulatory compliance for new and.
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Collaborate with other departments to ensure timely completion of all objectives and milestones, including Drug Manufacturing, Supply Chain, Product Development, Regulatory Affairs, Clinical Research & Development, Pharmacology & Toxicology, etc.
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The Senior Regulatory Affairs Specialist will drive compliance, mentor colleagues, and contribute to the company's continued success in the medical device industry. In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be responsible for leading regulatory strategy and driving registrations across international markets for Convatec's Advanced Wound Care division.
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Work with cross-functional teams (e.g.: R&D, Operations, Manufacturing Engineering, Service and Support, Product Management, Business Development, QA, QC, Regulatory Affairs) to drive resolution for internal issues/projects.
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This individual is the subject matter expert in GCP, is responsible for developing standards and partnering with Clinical Operations, Regulatory, Biostatistics, Safety, Medical Affairs, and other functions to establish and document risk based GCP processes and procedures.
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The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.
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Intern Job Description: Healthcare Industry Outreach and Compliance Research. Join our team and contribute to meaningful research efforts aimed at enhancing compliance and credentialing standards within the healthcare industry.
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