Regulatory Affairs Specialist

We are seeking an experienced Regulatory Affairs Specialist to support our diagnostic kit development projects, particularly in achieving compliance with international regulatory frameworks such as IVDR (EU), NMPA (China), and FDA (USA). The ideal candidate will have hands-on experience working with notified bodies or regulatory agencies, and a strong understanding of Quality Management Systems (QMS) and Next-Generation Sequencing (NGS) kits.Responsibilities:Lead regulatory strategy and submission processes for IVD products targeting IVDR, NMPA, and FDA approvals.Conduct gap assessments and prepare technical documentation in compliance with applicable regulations.Liaise with regulatory authorities, notified bodies, and testing laboratories to ensure smooth certification and approval processes.Support the implementation and maintenance of QMS (e.g., ISO 13485).Provide guidance on clinical performance studies, analytical validation, and risk management.Requirements:Proven experience in regulatory affairs for IVD products, especially with IVDR, FDA, or NMPA.Prior work experience at a certified testing laboratory or regulatory body is highly preferred.Strong knowledge of QMS standards and regulatory documentation.Experience with NGS-based diagnostic kits is a significant advantage.Excellent communication skills in English; ability to work independently and collaboratively.