Regulatory Affairs Expert

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,...

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 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,...

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...

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...

Role SummaryVerizon is seeking a highly skilled Senior Manager, Regulatory and Government Affairs to join our team. In this role, you will be responsible for representing and advocating for Verizon's interests before state regulatory commissions and relevant state legislative policy committees in California and other states.Key ResponsibilitiesDevelop and...

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...

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...

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 SummaryAs a Regulatory Strategy Consultant at Katalyst Healthcares and Life Sciences, you will play a crucial role in shaping the global regulatory strategy for our products. This involves providing strategic insight to the GRT on product development and serving as a Regulatory contributor to partner teams.Key Responsibilities Collaborate with regional...

Job OverviewWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Biogen. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Develop and implement regulatory strategies to support product development and commercializationCollaborate...

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...

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...

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...

Job Title: Regulatory Affairs ManagerAbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic guidance and support to our global development teams.Key Responsibilities:Develop and implement regulatory strategies for assigned products or...

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 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 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...