IT - Risk Management

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.

Qualifications we seek in you!

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

Preferred Qualifications/ Skills

• Strong technical knowledge
• Effective probing skills and analyzing / understanding skills