Senior documentation specialist for regulatory compliance

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:Senior Analyst/ Team Lead - Regulatory Compliance SpecialistWe're seeking a highly skilled Regulatory Compliance Specialist to provide expert support for compliance review of marketing materials, ensuring adherence to specific requirements and timelines.The ideal candidate will have extensive experience in FINRA & SEC Marketing Rules, with...

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...

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 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...

Compliance ManagerThe Compliance Manager role involves overseeing the implementation of regulatory compliance within our organization.Responsibilities:Ensure adherence to relevant laws and regulations, including IFSCA, SEZ, and SEBI AIF.Maintain accurate records and registers, ensuring timely completion of statutory audits.Draft and review legal documents,...

Job Overview:We are seeking a highly skilled professional to fill the role of Senior Document Review Specialist.Key Responsibilities:Ensure all documents meet quality standards and regulatory compliance.Assess document completeness, consistency, clarity, and correctness, identifying discrepancies, errors, and missing information.Account Management:Handle...

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...

TMF Specialist - Regulatory ComplianceWe are seeking a meticulous TMF professional to ensure the completeness, accuracy, and inspection readiness of assigned studies across allocated projects.Maintain inspection readiness for allocated studies; ensuring quality, compliance, and metadata consistency.Validate document types, properties, indexing, and scanning...

Job Description:We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions. Must have a deep knowledge of regulatory requirements and processes for medical devices. This role will involve...