Regulatory Specialist

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at...

Top Talent Sought for Regulatory Expert RoleJob Summary:We are seeking a seasoned professional to assume the role of Regulatory Specialist in our Hyderabad office.Main Responsibilities:Manage regulatory submissions and tariff determinations with precision and speedDraft and submit regulatory petitions, compliance reports, and responses to queries with...

Job description Analytical Specialist to support analytical development and testing activities within a Contract Development and Manufacturing Organization (CDMO) environment. The role requires expertise in analytical method development, validation, structural characterization, elucidation, impurity profiling, impurity identification and troubleshooting for...

Job Title: Regulatory Affairs SpecialistAbout This RoleWe are seeking a detail-oriented professional to support end-to-end submissions for global markets, focusing on regulatory affairs - CMC (Chemical, Manufacturing and Controls) aspects.Key ResponsibilitiesPreparing Variation documentsEvaluating post-approval CMC changes in compliance with global...

We're seeking a highly skilled Regulatory Affairs Specialist to join our team. This role combines domain expertise with product leadership, making you the bridge between industry workflows and cutting-edge AI solutions.Key Responsibilities:Provide subject matter expertise in Life Sciences/Pharma/Biotech/MedTech processes, regulations, and workflowsDevelop...

Regulatory Affairs ManagerWe are seeking a skilled regulatory affairs specialist to author, manage and receive clearances for FDA 510(k) submissions.About the RolePrepare, submit and manage FDA 510(k) premarket notifications for medical devices.Review regulatory documentation to ensure compliance with FDA regulations and standards.Advise product development...

Job Title: Regulatory Compliance SpecialistAt our organization, we are seeking an experienced Regulatory Compliance Specialist to join our team. The ideal candidate will have a strong background in regulatory compliance and be able to ensure that all submissions are periodically uploaded in the appropriate format.We are looking for someone who is aware of...

Job OverviewWe are seeking a Quality Assurance Specialist to join our team. In this role, you will be responsible for implementing and maintaining a Quality Management System (QMS) that ensures our products meet quality, safety, and regulatory standards.Key Responsibilities:Implementing and maintaining a QMS in accordance with ISO standardsEnsuring...

Job DescriptionVelocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to...

Job OverviewWe are seeking a skilled Regulatory Compliance Specialist to oversee FDA documentation and ensure compliance with domestic and international regulations.Key ResponsibilitiesManage multiple tasks, prioritize deadlines, and effectively communicate with FDA authorities and overseas customers.Plan, execute, and coordinate FDA activities according to...