Regulatory Compliance Change Assessor

Job Description- Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope.- Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system.- Liaise with other functions, including Process...

Key skills: Biocidal / disinfectant regulations, Chemical Safety & Regulatory Affairs, Hazard Communications, MSDS preparation (GLP/GHS), REACH registration Responsibilities:Responsible for preparing and implementing global strategic regulatory plan for chemicals, biocides and consumer chemical products (Cleaners, Disinfectants etc.). Represent and...

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 Summary This role involves ensuring a controlled documentation system and record retention in accordance with regulatory requirements. The successful candidate will be responsible for maintaining technical and non-technical documentation change systems, classifying and maintaining records, and enforcing documentation formatting standards. Key...

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...

Regulatory affairs professional with experience in managing product listings for different markets and ensuring full compliance with all regulations.Proven track record of collaborating with renowned global cosmetic brands to navigate and meet regulatory requirements across multiple regions, including the USA, Canada, Australia, New Zealand and Middle...

Job SummaryWe are seeking an experienced international regulatory professional to support regulatory submissions and compliance initiatives in the medical device industry.The ideal candidate will have a proven ability to navigate complex regulatory frameworks, particularly U.S. FDA and Health Canada requirements.They will be adept at coordinating...

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...

Regulatory Affairs Expert for Pharma and Life SciencesWe are seeking a highly skilled Regulatory Affairs expert to join our team. This individual will play a critical role in ensuring compliance with regulatory requirements in the pharmaceuticals and life sciences sector.Strong expertise in Life Sciences / Pharma / BioTech / MedTech processes, regulations,...

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...