Regulatory Affairs Specialist

Main Accountabilities : + Conduct research on regulatory changes & developments, regulatory submission requirements, and regultory processes, + Assist in the development and review of procedures, + Advise responsible personnel on regulatory requirements, develop options with recommendations, develop product regulatory strategies, and continuously assess project outputs & impacts on the regulatory strategy (including launch date), + Validate product labels, instructions for use, advertising and promotional materials, + Compile/organize content of regulatory applications & files, assess acceptability & completeness of documents, identify unmet needs & provide feedback, and ensure timely submissions, + Interact with regulatory authorities & execute regulatory processes, provide feedback on application review progress (including questions), coordinate & review answers to questions, and report on submission issues Studies and Experience : + Bachelor's Degree required, + Knowledge of regulatory requirements, guidance documents, and processes (local/global) with more than 5 years of practice in the field of IVD/MD in an international environment, + Basic knowledge of QMS requirements (QSR and ISO 13485 and/or local GMP if appropriate) with developed knowledge of design & change control processes, + Familiar with product profiles & technology, with company organization, and processes, + Familiar with regulatory agency organization (e.g. US FDA, EU Notified Bodies, and China NMPA), + Participation in local professional & trade organizations. Skills and Qualifications : + Analyze/understand regulatory requirements & identify solutions, and provide directions for proper implementation, + Routine problem solving, + Develop regulatory rationales, and justify the reasoning, + Ability to communicate to internal stakeholders & regulatory agencies or their representatives, + Work in an international environment.