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Minimum of 10 years of experience in CMC regulatory affairs within the biotechnology or pharmaceutical industry. We are seeking a highly experienced and strategic CMC Regulatory Affairs professional to join our growing team.
$231,000 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Regulatory and accreditation: Serves as the executive lead, collaborating with the Chief Medical Officer, Chief Nursing Officer, and PMG COO, when engaging in regulatory or governing organization site surveys.
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The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips’ Ultrasound business.
$178,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Collaborate closely with clinical development, regulatory affairs, medical affairs, and other stakeholders to ensure alignment and integration of clinical trial activities. Provide technical guidance and expertise to ensure compliance with regulatory requirements, GCP guidelines, and company SOPs throughout the clinical trial lifecycle, conducting regular audits and implementing corrective actions as needed.
$190,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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O Collaborate with laboratory staff, quality assurance, and regulatory affairs teams to document and assess deviations in laboratory processes and results. o Prepare deviation reports, impact assessment documents, and corrective and preventive action (CAPA) plans in accordance with regulatory standards and company policies.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Deviation Management: Collaborate with laboratory staff, quality assurance, and regulatory affairs teams to document and assess deviations in laboratory processes and results. Prepare deviation reports, impact assessment documents, and corrective and preventive action (CAPA) plans in accordance with regulatory standards and company policies.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Work with Quality and Regulatory Affairs to support regulatory activities specifically related to the introduction of new products (i.e., country registrations, submission and follow-up of 510k), as well as responding to internal and external audits (i.e., FDA, ISO, other regulatory bodies.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Familiarity with regulatory guidelines (e.g., CLIA, CAP, ISO) and quality management systems. o Stay up to date with industry regulations and best practices regarding clinical laboratory operations and ensure all documented processes comply with regulatory requirements.
$24 an hourExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Ensure new system features and transducers are diagnostic, meet the needs of our customers, and meet regulatory compliance. Collaborate with other disciplines (Product Management, Engineering, Regulatory, Marketing and Sales) to help expand our business.
$140,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Premera is seeking a talented and strategic people leader to join our Compliance, Ethics & Regulatory Affairs team. Lead and develop a team of professionals with the consulting and investigative skills and the understanding of legal/regulatory and business strategy necessary to provide effective Compliance and Ethics consulting and compliance monitoring services to internal business units and third parties to promote a culture of ethics and integrity.
Full-timeExpandApply NowActive JobUpdated 4 days ago
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