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The team developing industry-leading X-ray generation subsystems is looking for highly motivated regulatory engineers to join them in ensuring compliance and availability of these subsystems for CT scanners to all the global markets of interest.
As a Regulatory Engineer, you will be working on compliance activities for various medical devices global regulations.
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.
Requirements
- 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.
- Strong attention to detail.
This role requires a strong understanding of medical device regulations and a ability to communicate effectively with cross-functional teams.
