锦鲤求职岗位描述
Responsibilities:
1.To conduct technical documentation assessments against European Medical Device Regulation(MDR 2017/745) for Class I / IIa / IIb and/or Class III within the defined time frame in accordance with established procedures, maintaining a high standard of service delivery. primarily desk-based but occasionally may be on-site. Ensure that reviews are technically sound and in compliance with all applicable regulatory requirements.
2.Project manage assessments as appropriate, to maximise efficiencies, enhance client satisfaction, and ensure compliance with
regulatory requirements.
3.To assist with queries raised from product assessments.
4.Ensure adherence to SGS policies,NB 1639 procedures and processes.
5.Communication with team members and client with regards to the product assessment or other activities performed.
6.Support CE marking activities carried out by SGS including support of sales, technical coordinators.
7.Maintain personal competence and development in qualified specialist areas to be able to assess product technical documentation on an ongoing basis.
Requirements :
1.Bachelor’s degree or above in Medicine, Biomedical Engineering, Mechanical Engineering, Materials Science, Pharmaceutical Sciences, or other related scientific and engineering disciplines.
2.Four years professional experience in the field of dental implants/dental materials/dental instruments and/or of orthopedic
implants/orthopedic instruments, such as in design, manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
3.Previous working experience with Technical Documentation Assessments under MDR 2017/745.
4.Medical device knowledge on MDN 1103/MDN1208/MDN1209 and/or MDN1102/MDN1205, and MDS codes for MDR listed in Commission implementing regulation (EU) 2017/285.
5.Good communication techniques through electronic mediums.
6.Good Spoken and written English skills (as reports will be reviewed/queried in English) .