Regulatory Affairs Director

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...

Job SummaryThe Director/Senior Director, Regulatory Affairs will lead the development and execution of innovative CMC regulatory strategies to support the global development and commercialization of a drug/device combination product. This role requires dynamic leadership and direction to multi-disciplined project teams, working collaboratively with...

Company Overview: Ignite Human Capital is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer.Position Overview: We are seeking an accomplished and dynamic Senior Director of Regulatory Affairs...

Regulatory Affairs Director Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at Stryker. As a key strategist, you will be responsible for developing and implementing regulatory strategies for our Endoscopy business unit.Key Responsibilities:Develop and advise on product positioning, product entry and exit strategies,...

Job OverviewIgnite Human Capital is seeking a seasoned Senior Director of Regulatory Affairs to spearhead regulatory strategies and activities concerning the development and approval of cell therapy products.This pivotal role will provide strategic leadership, ensuring compliance with global regulatory standards while supporting organizational objectives.Key...

Job Title: Director of Quality Assurance and Regulatory AffairsWe are seeking a highly experienced and skilled Director of Quality Assurance and Regulatory Affairs to join our team at Inocras Inc. This is a critical role that will be responsible for building and maintaining quality systems for our next-generation sequencing clinical laboratory.Key...

Regulatory Affairs DirectorWe are seeking a highly motivated individual to provide leadership and support to global regulatory activities to achieve our strategic vision in obtaining worldwide approvals to market our products.The individual will represent Regulatory Affairs and work closely with cross-functional teams and development partners while managing...

About the RoleAbdera Therapeutics is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies and contingencies for assigned programs, in order to support Abdera's development objectives.Key ResponsibilitiesLead and prepare FDA...

Job SummaryWe are seeking a highly experienced Regulatory Affairs Director to lead our global regulatory efforts. As a key member of our team, you will be responsible for developing and implementing regulatory strategies to support the development, registration, and life-cycle management of our innovative products.Key ResponsibilitiesDevelop and execute...

Job Title: Director of Quality Assurance and Regulatory AffairsAbout the Role:The Director of Quality Assurance and Regulatory Affairs will be a key member of the executive team at Inocras Inc., responsible for building and maintaining quality systems for a next-generation sequencing clinical laboratory. With a strong focus on quality and regulatory...

Job DescriptionJob SummaryAbdera Therapeutics Inc. is a precision oncology company developing innovative targeted radiation therapies. We are seeking a highly experienced Regulatory Affairs professional to join our team as a Director/Senior Director Regulatory. The successful candidate will be responsible for developing and implementing regulatory strategies...

Job Summary:The Director, Regulatory Affairs is a key strategist responsible for developing regulatory strategy for the Endoscopy business unit and delivering Stryker's best-in-class Visualization products to market in the United States, Canada, and Europe.Through close partnership with business unit leadership, Marketing, R&D, Clinical, and Quality teams,...

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...

About the Role:Dexcom is seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs team as an Intern. As a Regulatory Affairs Specialist, you will play a critical role in preparing, submitting, and gaining regulatory approvals for our life-changing products, therapies, and customers around the world.Key...

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...

We are seeking a highly skilled Senior Regulatory Affairs Manager to lead our client's regulatory efforts in the San Francisco Bay Area.Key ResponsibilitiesDevelop and execute global regulatory strategies for assigned products throughout their lifecycle.Provide regulatory guidance to cross-functional teams on a wide range of issues.Anticipate and resolve...

Job OverviewStirling Q&R is seeking an accomplished and results-driven Senior Manager of Regulatory Affairs to lead the efforts in developing and executing regulatory strategies for our client's product portfolio.Key Responsibilities:Develop and execute global regulatory strategies for assigned products throughout their lifecycle.Provide regulatory guidance...

We are seeking a highly skilled Regulatory Affairs Director to join our team at Stryker. As a key strategist, you will be responsible for developing and implementing regulatory strategies for our Endoscopy business unit.The ideal candidate will have a strong understanding of regulatory requirements, including ISO, FDA, and International standards. You will...

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...

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...