What are the responsibilities and job description for the IB-Regulatory Engineer position at HUMAC INC.?
Job Details
Responsibilities:
Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations.
Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date
Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system
Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.)
Support regulatory audits and inspections to ensure post-market surveillance compliance.
Minimum Qualifications:
Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations
Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard.
Proficiency in interpreting, applying complex regulations, and preparing associated documentation.
Excellent interpersonal communication and collaboration skills
Bachelor s degree in engineering, Science or related area
Minimum of 2 years of experience working with medical devices regulations and quality management system.
proficiency with written English and with neutral English accent
