**FDA Implementation Manager** Position Objective: Ensure the proper implementation of regulatory requirements from the Food and Drug Administration (FDA) of the United States, with emphasis on the integration and follow-up of the 510(k) submission. The goal is to ensure that production, documentation, and quality management processes comply with applicable regulations, facilitating access to international markets and organizational inspectability. Main Responsibilities: * + Regulatory Implementation + Execute compliance plan with FDA requirements (21 CFR Part 807, 21 CFR Part 820 – QSR, 21 CFR Part 11\). + Align internal processes with FDA, ISO 13485, ISO 14971, and Mexican NOMs (e.g., NOM\-241\-SSA1\). + Integrate technical and testing information into regulatory documentation for 510(k). + Develop, review, and consolidate manuals, SOPs, records, and reports required by FDA. + Prepare sections of the 510(k): device description, substantial equivalence, performance data, labeling, and risk management. + Ensure traceability, change control, and versioning of regulatory documentation. + Prepare the organization for internal and external audits (FDA, ISO). + Follow up on CAPA plans arising from audit observations. + Promote a culture of inspectability across all involved departments. + Conduct risk analyses (FMEA, biocompatibility, sterilization, packaging, usability). + Supervise equipment, process, and software validations in accordance with FDA guidelines. + Collaborate in training programs on FDA regulations for technical and administrative teams. + Foster a culture of compliance and regulatory quality within the organization. + Maintain regulatory surveillance regarding changes in regulations and relevant FDA guidance. Position Profile: Education: * + Bachelor’s degree in Biomedical Engineering, Biotechnology, Pharmacy, Chemistry, or related field. + Preferred: Master’s degree in Regulatory Affairs, Quality, or related disciplines. Experience: * + 4–6 years in Regulatory Affairs, Quality, or Compliance within medical devices or pharmaceutical industries. + Proven experience in compiling documentation for FDA submissions (510(k)) and international audits. + Familiarity with quality management systems (ISO 13485, ISO 14971\). * Technical Knowledge: * + FDA regulations applicable to medical devices: 21 CFR Part 807, 820, and 11\. + NOM\-241\-SSA1 and Mexican regulatory framework. + Good Manufacturing Practices (GMP). + Risk management and validation processes. + Advanced English (essential for technical documentation and communication).