Qualifications: Bachelor’s degree or equivalent in Engineering or Science or related discipline. 7-10 years of work experience in Regulatory Affairs 5+ years prior MDR/MDD/CE mark submissions Background in preparing major regulatory submissions and supportive amendments or supplements, and collaborating with regulatory authorities Experience in interpretation of regulations, guidelines, policy statements, etc. Required Skills: Strong social skills with the ability to partner effectively with medical, scientific, manufacturing and other cross-functional stakeholders. Ability to read, analyze and interpret engineering specifications, scientific information, professional journals, technical procedures and government regulations. Experience developing reports, specifications and complex regulatory submissions, including IDE, PMA, CE Design Dossiers and Technical Files. Ability to present information clearly and respond effectively to questions from internal stakeholders and external regulatory agencies. Strong problem-solving skills, including the ability to define issues, collect and assess data, establish facts and draw valid conclusions. Ability to review technical and clinical literature and documents and extract key concepts relevant to regulatory strategy and execution. Experience interacting with auditors and Competent Authority representatives and managing internal and external audits in accordance with established processes, procedures and international standards. Ability to lead, influence and align project teams to achieve shared goals. Experience engaging senior management on significant matters requiring coordination across organizational units. Ability to balance strategic and tactical priorities, moving effectively between high-level perspective and detailed execution. Knowledge of Quality Management System requirements for medical devices, particularly ISO 13485.
