Regulatory Affairs and Quality Assurance Leader

About the RoleTerns Pharmaceuticals is seeking a highly experienced and skilled Vice President, Regulatory Affairs and Quality Assurance to lead our regulatory and quality functions. As a key member of our Senior Leadership Team, you will be responsible for developing and executing regulatory strategies, managing global health authority interactions, and...

Hartmann Young is seeking a seasoned professional to lead its quality assurance and regulatory affairs efforts. The ideal candidate will have a strong background in managing global regulatory and quality strategies, with a proven track record of success in FDA and CE-marking submissions for medical devices and in vitro diagnostics.Key...

About the RoleTerns Pharmaceuticals is seeking a highly skilled Senior Regulatory Affairs and Quality Assurance Director to lead our regulatory and quality functions. As a key member of our Senior Leadership Team, you will be responsible for developing and executing regulatory strategies, managing global health authority interactions, and overseeing quality...

About Spinal ElementsSpinal Elements is a leading medical device company that specializes in the design, development, and commercialization of innovative spinal implant technologies. Our mission is to deliver positive surgical outcomes that exceed surgeon and patient expectations.Job SummaryWe are seeking a highly experienced Vice President of Regulatory...

Regulatory Affairs ManagerThe Thor Companies is seeking a highly skilled Regulatory Affairs Manager to lead our regulatory strategy and submission processes for Chemistry, Manufacturing, and Controls (CMC) associated with Abbreviated New Drug Applications (ANDAs) and generic products.Key Responsibilities:Develop and implement regulatory strategies for CMC...

The Regulatory Affairs Director at Thor Companies will lead the development and implementation of regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) components of Abbreviated New Drug Applications (ANDAs) and generic products. This role requires a deep understanding of regulatory requirements, strong project management skills, and the...

The Quality and Regulatory Leader will oversee all aspects of quality management and regulatory compliance related to our SaMD products. This role is critical to ensuring that the software solutions meet international standards and regulatory requirements while maintaining the highest levels of data security and patient safety.Key Responsibilities:Develop,...

Job Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at GForce Life Sciences. The ideal candidate will have a strong background in regulatory compliance and quality systems.Key Responsibilities:Implement and maintain quality systems to ensure compliance with regulatory...

The Director of Regulatory Affairs will play a key role in providing technical and managerial leadership to resources through both direct and indirect reporting structures. This role will be responsible for leading regulatory service projects by providing robust regulatory strategies, leading interactions with regulatory agencies, and preparing regulatory...

Director of Regulatory AffairsThe Director of Regulatory Affairs will play a key role in providing leadership to resources through direct and indirect reporting structures. This role will lead regulatory service projects by providing robust regulatory strategies, leading interactions with regulatory agencies, and preparing regulatory applications for drug...

Job Summary:The Regulatory Affairs Specialist at Orion Group supports the development and implementation of the global regulatory strategy for company cosmetic and OTC products. This role involves reviewing, planning, and preparing regulatory documents and labeling for product registrations and updates.Key Responsibilities:Review product labeling for...

Regulatory Affairs StrategistDevelop and execute regulatory strategies for oncology assetsCollaborate with cross-functional teams to ensure regulatory compliancePrepare and submit regulatory documents to global authoritiesKey Responsibilities:Lead regulatory submissions for oncology assetsInteract with FDA and global regulatory authoritiesEnsure product...

Regulatory Affairs Director - Permanent - RemoteProclinical Staffing is seeking a Director, Regulatory Affairs for a global medical device company. This is a permanent role based remotely out of the San Francisco Bay Area.Primary Responsibilities:In this role, you will provide direct support to company operations for their globally distributed products. This...

Job Title: Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Wellington Executive Search. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and maintaining a strong reputation in the industry.Key Responsibilities:Collaborate with...

Regulatory Affairs SpecialistLocation: Our innovative client is seeking a Regulatory Affairs Specialist to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key Responsibilities:Prepare and coordinate...

Key Responsibilities:As a Quality Assurance and Regulatory Specialist at Applechem, you will be responsible for managing customer inquiries and complaint resolution processes related to product quality. You will also oversee the Corrective and Preventive Action (CAPA) program under the direction of the Quality Assurance Manager.Key Responsibilities...

Job Title: Director of Quality AssuranceLocation: New JerseyPosition Overview:We are seeking a highly experienced and motivated Director of Quality Assurance to lead a QA team in New Jersey. The ideal candidate will have a strong background in aseptic manufacturing and a proven track record in quality assurance within a CDMO environment. This role will be...

Job Title: Senior Regulatory Affairs SpecialistLocation: San Diego, CAExperience: Must have experience composing submissions for IVD devicesPosition Overview:The Sr. Regulatory Affairs Specialist will coordinate the collection of technical information and prepare regulatory submissions for in vitro diagnostic (IVD) and medical device licenses for various...

Job Title: Senior Regulatory Affairs SpecialistLocation: Cypress HCMExperience: Must have experience composing submissions for IVD devicesPosition Overview:The Senior Regulatory Affairs Specialist will coordinate the collection of technical information and prepare regulatory submissions for in vitro diagnostic (IVD) and medical device licenses for various...

Job Title: Regulatory Affairs ManagerWillson International Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for managing provisions of broker regulations set forth in 19 CFR 111 and various participating government agencies to ensure requirements are met or...