Regulatory Affairs Specialist

Role: Regulatory Affairs specialist focusing on global compliance and regulatory submissions for IVD products. Primary objectives include ensuring product adherence to international regulations across markets such as FDA (US), IVDR (EU), and others, supporting lifecycle management, and maintaining compliance documentation. Responsibilities encompass preparing submissions, monitoring global regulation changes, managing product registration and licensing, collaborating with R&D, Quality, and Commercial teams to embed regulatory requirements into development and manufacturing, and supporting post-market surveillance activities. The role also involves internal training, audit support, change assessment, and strategic regulatory planning. Qualifications: Bachelor's degree, minimum 3 years in regulated medical devices or IVD industry, with practical knowledge of international markets and standards (ISO 13485, ISO 14971, MDSAP). Experience with antibody-based diagnostics and eQMS platforms like MasterControl or Veeva Vault is preferred. Skills include strong analytical, organizational, and communication abilities, with a focus on cross-functional collaboration. High-Value: expertise in IVD regulation (EU IVDR), US FDA, MDSAP, and international submissions, particularly in diagnostics development stage, post-market compliance, and lifecycle support. Location: Primarily remote with occasional travel (<20%). The position offers a full-time schedule and competitive compensation within a broad pay range.