IVD Regulatory Affairs Manager

Opportunity for a Regulatory Affairs Manager at CorDxCorDx, a prominent biotechnology firm focused on advancing global health solutions, is seeking a Regulatory Affairs Manager to enhance our proactive Regulatory Affairs team. In this pivotal role, you will be instrumental in ensuring adherence to FDA regulations for our In Vitro Diagnostics (IVD)...

Regulatory Affairs Specialist Opportunity at CorDxCorDx, a prominent biotechnology firm committed to advancing global health, is seeking a Regulatory Affairs Specialist to enhance our proactive Regulatory Affairs division. In this pivotal role, you will be instrumental in ensuring adherence to FDA standards for our In Vitro Diagnostics (IVD) offerings.Key...

Position Overview:We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our Diagnostics Regulatory Affairs team. This role is pivotal in overseeing the regulatory processes associated with in vitro diagnostic (IVD) products throughout their lifecycle, including new product development and ongoing market compliance.Key...

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...

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...

Position OverviewGenalyte, Inc., a pioneer in innovative diagnostic solutions, is in search of a highly experienced and driven Senior Regulatory Affairs Specialist to enhance our dynamic workforce. In this crucial position, you will utilize your knowledge to navigate intricate regulatory frameworks, ensuring our revolutionary products adhere to all...

Position OverviewGenalyte, Inc., a frontrunner in pioneering diagnostic technologies, is in search of a proficient and driven Senior Regulatory Affairs Specialist to enhance our innovative team. In this crucial position, you will utilize your regulatory expertise to navigate intricate compliance frameworks, ensuring our revolutionary products adhere to all...

Position OverviewGenalyte, Inc., a pioneer in innovative diagnostic solutions, is on the lookout for a highly experienced and driven Senior Regulatory Affairs Specialist to enhance our dynamic workforce. In this crucial position, you will utilize your regulatory expertise to navigate intricate compliance landscapes, ensuring our revolutionary products adhere...

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...

Join Our Team as a Regulatory Affairs ManagerWe are seeking a skilled Regulatory Affairs Manager to become part of our client's team and have a significant role in introducing new products to the market. As the Regulatory Affairs Manager, you will be responsible for leading the regulatory strategy and overseeing submissions for new product releases within...

R&D Partners is in search of a Senior Regulatory Affairs Consultant. Key Responsibilities: Support ongoing marketed products by reviewing engineering modifications, promotional materials, labeling, and documentation to ensure compliance with both US and international regulatory standards.Draft and maintain product technical files while overseeing compliance...

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...

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,...

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:** Director of Regulatory Affairs**Job Category:** Exempt**Department:** R&D**Direct Report:** N/A**Location:** N/A**Travel Required:** N/A**Salary Range:** N/A**Position Type:** Full-time/OnsiteJob SummaryModular Medical Inc is seeking a highly experienced Director of Regulatory Affairs to lead our regulatory strategy and ensure...

About Radionetics OncologyRadionetics Oncology is a clinical-stage biotechnology company dedicated to the discovery and development of innovative radiopharmaceuticals for the treatment of various oncology indications. With a strong focus on novel radiotherapeutics, the company is poised to capitalize on the growing demand for effective cancer...

Job Description**About CorDx**CorDx is a multinational biotechnology organization dedicated to pushing the boundaries of innovation and supply in global health. With a global presence and a team of over 2,100 employees, CorDx delivers rapid testing and point-of-care medical device solutions for the detection of infectious diseases, pregnancy, drugs of abuse,...

Exciting Opportunity in Regulatory AffairsAre you an experienced professional with a strong background in global regulatory management and project execution? As a pivotal member of Cypress HCM, you will be instrumental in advancing our objectives within the pharmaceutical sector. In the role of Regulatory Affairs Director, you will be responsible for...

Strategic Role in Regulatory AffairsAre you an experienced professional with a strong interest in international regulatory management and project oversight? As a key player in the pharmaceutical sector, you will assume a vital position in steering the development of innovative products while ensuring adherence to local and global regulations.Key...

Job SummaryWe are seeking a highly experienced Regulatory Affairs Director or Senior Regulatory Affairs Director to join our team at Kura Oncology. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with governing laws, regulations, and internal policies and procedures.Key ResponsibilitiesEnsure U.S....