Medical Device Regulatory Affairs (EU Registration)

Responsibilities

• Participate in new project initiation, regulatory input and interpretation, and EU regulatory pathway planning.
• Responsible for the collection, organization, and compilation of product registration dossiers; conduct technical reviews of submission documents and submit files to EU Notified Bodies.
• Interface with Notified Bodies and other international regulatory authorities, monitor submission progress, and respond promptly to queries to ensure timely certification.
• Regularly collect EU market laws and regulations in a timely manner, and complete internal implementation and training.
• Maintain and manage certificates, documentation, and post-market surveillance records; complete relevant submissions as needed and collaborate with relevant departments to ensure ongoing post-market compliance.
• Perform other tasks assigned by department leadership.

Responsibilities

• Participate in new project initiation, regulatory input and interpretation, and EU regulatory pathway planning.
• Responsible for the collection, organization, and compilation of product registration dossiers; conduct technical reviews of submission documents and submit files to EU Notified Bodies.
• Interface with Notified Bodies and other international regulatory authorities, monitor submission progress, and respond promptly to queries to ensure timely certification.
• Regularly collect EU market laws and regulations in a timely manner, and complete internal implementation and training.
• Maintain and manage certificates, documentation, and post-market surveillance records; complete relevant submissions as needed and collaborate with relevant departments to ensure ongoing post-market compliance.
• Perform other tasks assigned by department leadership.

Qualifications

• Bachelor’s degree or above is required, in Medical Device Engineering, Biomedical Engineering, Materials Science, Stomatology/Dentistry, or a related field. Advanced degrees preferred (e.g., Masters).

Required Skills

• Demonstrated strong organizational coordination, learning, execution, and documentation skills; detail-oriented, conscientious, with a strong sense of responsibility and excellent teamwork capabilities.
• Proficient in the CE certification process for non-active medical devices, with a proven track record of successful CE certification for multiple resin-based dental medical device projects; thorough knowledge of relevant EU medical device regulations.
• Excellent written and verbal communication skills (English as a working language), proficiency in Chinese is a plus.

Preferred Skills

• Proficiency in Chinese is a plus.

Equal Opportunity Statement

Include a statement on commitment to diversity and inclusivity.