Senior Regulatory Specialist

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...

Position OverviewInternational Regulatory Specialist (EU MDR) - Medical DeviceRole Summary:The International Regulatory Specialist is primarily accountable for ensuring adherence to EU regulatory standards and oversees the international regulatory submission framework.Essential Qualifications:Required Qualifications:Education: Bachelor's degree in a relevant...

Position OverviewInternational Regulatory Specialist (EU MDR) - Medical DeviceRole Summary:The International Regulatory Specialist is tasked with ensuring adherence to EU regulatory standards and oversees the comprehensive international regulatory submission process.Essential Qualifications:Required - Minimum Qualifications:Education: Bachelor's...

Job OverviewInternational Regulatory Specialist (EU MDR) - Medical DevicePosition SummaryThe International Regulatory Specialist is tasked with ensuring adherence to EU regulatory standards and is responsible for overseeing the international regulatory submission framework.Essential Qualifications:Required - Minimum Qualifications:Education: Bachelor's...

About Danaher Corporation: Danaher Corporation is a global leader in the life sciences and diagnostics sectors, committed to innovation and excellence in our products and services.Position Overview: We are seeking a Senior Specialist in Regulatory Affairs for Core and NGS Technologies. This role is integral to our Quality Assurance and Regulatory Affairs...

Regulatory Affairs SpecialistThe Regulatory Affairs Specialist IV at Cypress HCM will oversee the organization and submission of regulatory documents related to in vitro diagnostics and medical device licenses to appropriate regulatory bodies. This role will also involve managing clinical trial studies, including those conducted at external sites when...

Job DescriptionJob DescriptionInternational Regulatory Specialist (EU MDR) - Medical DeviceJob DescriptionThe International Regulatory Specialist has primary responsibility for compliance with EU regulatory requirements and owns the international regulatory submission process. Qualifications:Must Have - Minimum Requirements:Education: Bachelor's degree...

We are hiring in our Diagnostics Regulatory Affairs team here in San Diego, and are looking for a Senior Regulatory Affairs Specialist, IVD Product Lifecycle responsible for new product development, on-market, and international regulatory activities associated with US FDA, EU Notified Body, and other international regulatory agencies. This position is...

Regulatory Affairs Specialist The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...

Join a dynamic, employee-owned environmental consulting firm based in the vibrant San Francisco Bay Area that specializes in providing comprehensive regulatory and environmental services. We are committed to sustainable development and ensuring compliance with environmental regulations while fostering innovative solutions. Position Overview: We are seeking a...

Senior Regulatory Affairs SpecialistGenalyte, Inc., a frontrunner in cutting-edge diagnostic solutions, is seeking a highly qualified and driven Senior Regulatory Affairs Specialist to become part of their innovative team. In this position, you will be tasked with navigating intricate regulatory frameworks to guarantee adherence to all standards and...

Position Overview:Reporting directly to the Senior Vice President of Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will spearhead and engage in regulatory initiatives related to IND/CTA preparations and ongoing maintenance to facilitate both new and existing development programs. This position demands a proactive,...

Job SummaryCrinetics Pharmaceuticals, Inc. is seeking a highly experienced Senior Director of Medical Information to lead all activities related to the medical information specialist group. This role is critical in ensuring the development and maintenance of a comprehensive product knowledge database and the accurate and timely dissemination of medical...

Position Overview:Reporting to the Senior Vice President of Regulatory Affairs, the Regulatory Affairs Senior Manager or Associate Director will spearhead and engage in regulatory initiatives related to IND/CTA preparation and ongoing maintenance to facilitate both new and existing development programs. This position necessitates a proactive,...

Job Description Job Title: Regulatory Affairs Specialist Company: US Tech Solutions Job type: Contract Duration: 12 months ID: 5175 Department: Regulatory Affairs Prerequisites: BS/BA degree in Scientific Discipline (Masters or higher preferred) A minimum of 7 years in the pharmaceutical industry A minimum of 5 years CMC regulatory (biologics preferred)...

Job DescriptionJob DescriptionBackgroundTellus Civic Science Corporation (Tellus) provides world-class science, engineering, research, planning, and consulting solutions focused on resource conservation and restoration, carbon reduction, and sustainability to mitigate the impacts of climate change, strengthen community resilience, preserve our environment,...

Senior Regulatory Affairs Specialist (Locals Only) At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest technologies that enhance human life and be a...

Senior Regulatory Affairs Specialist (Locals Only) At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest technologies that enhance human life and be a...

R&D Partners is looking for a Senior Regulatory Affairs Specialist III. Key Responsibilities: Support for marketed products, including reviewing engineering modifications, labeling, promotional content, product alterations, and documentation to ensure compliance with both US and international regulatory standards.Draft and maintain submissions and product...