Medical Device Regulatory Affairs (EU Registration)

SHINING 3D; Stuttgart; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading medical device company in Stuttgart is looking for a qualified regulatory affairs specialist. You will be responsible for managing the CE certification process for non-active medical devices, compiling product registration dossiers, and interfacing with Notified Bodies. The ideal candidate holds at least a Bachelor's degree in a relevant field and possesses excellent organizational and communication skills. This position offers an opportunity to work in a dynamic environment with a focus on regulatory compliance.

Qualifikationen

• Bachelor's degree or above in Medical Device Engineering or related field is required.
• Proven track record of successful CE certification for resin-based dental medical devices.
• Excellent written and verbal communication skills in English.

Aufgaben

• Participate in regulatory input and EU pathway planning.
• Compile product registration dossiers for submission.
• Interface with Notified Bodies to ensure timely certification.

Kenntnisse

Organizational skills

Detail-oriented

Teamwork capabilities

Communication skills in English

Proficiency in CE certification process

Ausbildung

Bachelor’s degree in relevant field

Master’s degree preferred

Jobbeschreibung

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.