Job Summary:
The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices). The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards.
Responsibilities (Specific tasks, duties, essential functions of the job)
Qualifications (Experience and Education)
Bachelor of Science degree
5-7 years of regulatory affairs experience in medical device industry, preferably with respiratory devices. Current experience leading multiple successful 510(k) clearances and CE marking is required, and experience with additional global regulatory pathways is preferred
Strong understanding of medical device product life cycle and regulatory requirements. In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR. Knowledge of ISO 14971 risk management for medical devices. Proficiency in database systems and advanced Microsoft Excel skills for reporting and analysis. Understanding of continuous improvement principles.
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