Regulatory Affairs Specialist

About SynchronSynchron is a clinical-stage endovascular brain computer interface (BCI) company. Our mission is to develop a first-in-class commercial BCI for more than 100 million people worldwide with upper limb impairment. We are committed to bringing life-changing technologies to people.Job Title: Senior Regulatory Affairs SpecialistThe Senior Regulatory...

Regulatory Affairs SpecialistSynchron LLC 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 planning and executing regulatory submissions and ensuring regulatory compliance.Key Responsibilities:Provide regulatory strategy and guidance on medical devices throughout...

Job Title: Associate Director/Director, Regulatory AffairsFairway Consulting Group is seeking a highly experienced Associate Director/Director, Regulatory Affairs to join our team. This is a unique opportunity to work with a leading biopharmaceutical company and contribute to the development of innovative global regulatory strategies.Key...

Job Title: Director of Regulatory AffairsJob Summary:The Director of Regulatory Affairs will oversee the daily operations of the Regulatory Affairs Department at NYC Health and Hospitals, ensuring compliance and patient safety goals are met. This role will develop optimal strategies throughout the regulatory process, promote regulatory readiness, and assist...

Job DescriptionAt NYC Health Hospitals, we are seeking a highly skilled and experienced Director of Regulatory Affairs to join our team. As a key member of our leadership team, you will be responsible for overseeing the daily operations of the Regulatory Affairs Department and ensuring compliance with regulatory requirements.Key Responsibilities:Provide...

Job SummaryAs a seasoned Regulatory Affairs professional, you will play a critical role in ensuring the success of our pharmaceutical applications by effectively liaising with regulatory agencies, coordinating submissions, and providing strategic guidance to cross-functional teams. Your expertise in regulatory affairs, combined with your ability to navigate...

About the RoleOscar Health is seeking an experienced Attorney to join our Regulatory Legal & Government Affairs team. As a key contributor to the development of our state and legal department, you will leverage your expertise in state legislative and regulatory processes to drive our company's growth and success.Responsibilities:Manage a team of analysts to...

About the JobSenior Manager Regulatory Affairs at Workforce Solutions Virens GlobalA well-established consumer products corporation is seeking a Regulatory Affairs Manager. Key responsibilities include:Key ResponsibilitiesEnsure completion of necessary documents during the development life cycle and launchEnsure compliance with policies and product...

Job SummaryOscar Health is seeking a highly skilled Regulatory Affairs Associate to join our Corporate Counsel team. As a key member of our team, you will be responsible for managing the Independent Dispute Resolution process in assigned jurisdictions.The ideal candidate will have a strong background in legal or regulatory affairs, with experience working...

Regulatory Affairs Job Description **Overview** KMR Search Group is seeking an experienced Regulatory Affairs Associate Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with global regulations and guidelines governing pharmaceutical drug development. **Responsibilities** *...

Global Regulatory Affairs ExpertDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.With more than 100 years of scientific expertise and a presence in more than 20...

Job Summary:Innova Solutions is seeking a highly skilled Regulatory Affairs Assistant - II to join our team. As a key member of our Regulatory Affairs department, you will be responsible for performing data entry using Client RIM System to enter relevant information to support key CMC RA stakeholders.Key Responsibilities:Perform data entry using Client RIM...

Job DescriptionJob Title: Global Regulatory Affairs Labeling Strategy ExpertCompany: Daiichi Sankyo, Inc.Job Summary:We are seeking a highly skilled Global Regulatory Affairs Labeling Strategy Expert to join our team. As a key member of our Global Regulatory Team, you will be responsible for providing strategic and operational leadership on product labeling...

Job Title: Senior Counsel for Commercial Regulatory AffairsThe City of New York is seeking a highly qualified Senior Counsel for Commercial Regulatory Affairs to join our team. As a key member of our legal department, you will provide expert advice on commercial regulatory matters, ensuring compliance with laws and regulations.Key Responsibilities:Provide...

Job Summary:The Regulatory Specialist at Globus Medical is responsible for drafting, submitting, and gaining clearance for 510(k) submissions and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products.This role entails developing FDA submissions, requiring working knowledge of products under review and...

Job Title: Regulatory Affairs DirectorAt LVMH Perfumes & Cosmetics, we are seeking a highly skilled Regulatory Affairs Director to lead our operational regulatory affairs team on cosmetics and OTC drugs for the USA and Canada. This role will be the primary contact to various governmental agencies in the USA and Canada, requiring a deep understanding of...

Job DescriptionThe Quality and Regulatory Affairs Specialist-BI plays a pivotal role in the implementation of the Clinical Quality and Patient Safety Performance Improvement Program. This healthcare professional coordinates the planning, monitoring, and evaluation of the Quality and Regulatory Readiness program, ensuring regulatory compliance and promoting...

We are seeking an experienced Statutory Accounting Consultant with a strong background in regulatory reporting and statutory accounting principles, particularly within the insurance industry.The consultant will be responsible for preparing, reviewing, and ensuring the accuracy of statutory financial statements and reports, in compliance with regulatory...

Job Title: Regulatory and Clinical Trials SpecialistWe are seeking a highly skilled Regulatory and Clinical Trials Specialist to join our team at Weill Cornell Medical College. The successful candidate will be responsible for managing the development of investigator-initiated clinical trials and ensuring compliance with federal, state, and institutional...

Job SummaryThe Global Medical Director, Hemophilia is a key member of the Therapeutic Area team, responsible for providing medical expertise and strategic guidance to support the development and commercialization of hemophilia therapies. This role requires a strong understanding of the hemophilia disease state, as well as experience in medical affairs,...