International Regulatory Specialist

We are hiring a Senior Regulatory Affairs Specialist for our Diagnostics Regulatory Affairs team who will be 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 focused on in vitro diagnostic systems including assay,...

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...

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...

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...

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...

Responsible for the preparation and maintenance of domestic and international regulatory filings to meet corporate objectives and for the timely completion of other assigned activities related to regulatory support activities including all programs r Regulatory Affairs, Regulatory, Specialist, Product Development, Medical, Support, Healthcare, Business...

About CorDxCorDx is a global biotechnology firm dedicated to advancing innovation and supply in the realm of global health. With a workforce exceeding 2,100 professionals worldwide, we serve millions of users across more than 100 countries. Our focus is on delivering rapid testing and point-of-care medical device solutions for the detection of infectious...

Join Our TeamInvivoscribe is a premier organization committed to Precision Diagnostics aimed at improving lives. With over 25 years of expertise, we have been leaders in the global standardization of testing and providing access to innovative cancer therapies.Located in the dynamic region of San Diego, California, our international reach enables us to...

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...

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...

Job TitleLead Regulatory Affairs Specialist-Coronary VascularJob SummaryAs a Lead Regulatory Affairs Specialist, you will have a key role in ensuring the safety, effectiveness, and compliance of Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products with global regulatory standards. Role Highlights:Provide guidance to internal teams...

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,...

Exciting Career OpportunitySan Diego Medical ExaminerAIR QUALITY REGULATORY SPECIALISTThe San Diego Medical Examiner is dedicated to safeguarding public health by addressing the detrimental impacts of air pollution, ensuring adherence to air quality standards, promoting community engagement, and implementing effective programs. We are currently seeking...

Job SummaryWe are seeking an experienced Executive Director, Toxicology to join our team at International Staff Consulting. This is a key leadership role that will oversee the activities of our Toxicology group and provide strategic direction to ensure the successful execution of toxicology studies.Key ResponsibilitiesProvide leadership and oversight to the...

Key Responsibilities: Oversee and support regulatory policy initiatives within the Regulatory Science and Policy team. Demonstrate proficiency in navigating a matrix organization and managing uncertainty to facilitate decision-making across various teams. Collaborate with regulatory leads to provide cross-functional support on both strategic and...

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...

Lead Specialist in Regulatory Compliance At ACON Laboratories, we are dedicated to enhancing healthcare through innovative medical devices that assist in diagnosing various health conditions. Our mission is to optimize processes and reduce expenses for both healthcare providers and patients. Join our team to contribute to the advancement of cutting-edge...

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...