Regulatory Affairs Specialist

Regulatory Affairs SpecialistAjinomoto Bio-Pharma is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for providing support for all internal and external regulatory-related activities.Key Responsibilities:Collaborate with internal team members to maintain compliance with...

At CorDx, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for assisting in the preparation, compilation, submission, and maintenance of regulatory filings and registrations, including DeNovo and 510(k) submissions for IVD products.The ideal candidate will have a strong understanding of regulatory...

Job Title: Regulatory Affairs Specialist - CMCNeurocrine Biosciences is seeking a highly skilled Regulatory Affairs Specialist - CMC to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and execution of regulatory strategies for assigned commercial and development projects.Key...

At DivIHN Integration Inc, we're seeking a skilled Regulatory Affairs Specialist to join our team. This is a unique opportunity to make a meaningful impact in the field of regulatory affairs.About the Role:This position will play a crucial role in coordinating change order reviews, allowing our full-time RA professionals to focus on key strategic...

At Abbott Laboratories, we're seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our Regulatory Affairs department, you'll play a critical role in ensuring compliance with US, EU, and international regulations and standards for our diagnostic products.Key Responsibilities:Provide regulatory support for diagnostic...

At Abbott Laboratories company, we are seeking a highly skilled Regulatory Affairs Specialist II to join our team. This role will be responsible for providing regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards.Key Responsibilities:Reviews and approves...

Regulatory Affairs Specialist - Continuous Glucose MonitoringDexcom Corporation is a pioneer in continuous glucose monitoring (CGM). We are seeking a Regulatory Affairs Specialist to support the growth and expansion of our CGM Systems.As a Regulatory Affairs Specialist, you will assist in the support and sustaining activities for Dexcom's CGM products. You...

At CorDx, we are seeking a highly skilled Regulatory Coordinator to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Assist in the preparation, compilation, and submission of regulatory filings and...

Job Title: CMC Regulatory Affairs Data Entry SpecialistFoster City, CAJob Summary:RICEFW Technologies is seeking a highly skilled CMC Regulatory Affairs Data Entry Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for performing data entry using Gilead RIM System to support key CMC RA...

About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Specialist to lead our advertising and promotion regulatory efforts. As a key member of our team, you will be responsible for ensuring compliance with FDA regulations and guidelines for commercial materials.Key Responsibilities:Lead cross-functional collaboration to ensure timely reviews...

About Dexcom's Summer Intern Program:Are you looking to spend your summer working with innovative technology and changing the lives of patients with diabetes? Dexcom's U.S. 12-week internship program provides an experience-driven program aimed at developing the next generation of talent. Our onsite, hybrid, and remote work models ensure that we can invite...

Job OverviewCypress HCM is seeking a highly skilled Regulatory Affairs Specialist to coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies.Key ResponsibilitiesCoordinate submission and review of documents for inclusion in Design History...

Regulatory Affairs SpecialistYoh is seeking a highly skilled Regulatory Affairs Specialist to join our team in St. Louis, Missouri. This individual will be responsible for planning and authoring pharmaceutical documents, ensuring compliance with regulatory requirements. The position offers a hybrid schedule and the opportunity to work with a growing...

About Dexcom's Summer Intern Program:Are you looking to spend your summer working with innovative technology and changing the lives of patients with diabetes? Dexcom's U.S. 12-week internship program provides an experience-driven program aimed at developing the next generation of talent. Our onsite, hybrid, and remote work models ensure that we can invite...

Job Title: Regulatory Affairs LeaderCompany Description: Trebla Talent is a pioneering cell therapy biotech focused on developing innovative immunotherapies for cancer treatment.Role Description: As the Head of Regulatory Affairs, you will drive strategic regulatory decisions across the entire portfolio, leading a growing regulatory team and playing a key...

Job OverviewCorDx is a leading biotech organization dedicated to delivering innovative medical device solutions. We are seeking an experienced Associate Director of Regulatory Affairs to lead our regulatory submissions and ensure compliance with applicable regulations.This role will play a crucial part in the successful approval and launch of our medical...

About Cala HealthCala Health is a pioneering medical technology company dedicated to freeing people from the burden of chronic disease. Our innovative solutions have empowered thousands of individuals to regain control over their lives with confidence and ease.The OpportunityWe are seeking a highly skilled Regulatory Affairs Specialist to join our dynamic...

Job Title: Director, Regulatory AffairsCodera is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. We are seeking a highly skilled Director, Regulatory Affairs to support the development and execution of domestic and international regulatory strategy for Codera.Key...

About the Role:You will be a seasoned professional in the Regulatory Affairs space with specific experience in IVD and POC products. Your experience in US regulatory affairs submissions, such as 510(k) and/or PMA, will be valuable in this role. With at least 10+ years of experience in this field, you will be able to take the lead with submissions and prepare...

Job Title: Regulatory Affairs Specialist II - Medical DeviceVolt is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Develop and implement regulatory strategies for...