Medical Device Certification Specialist

2 weeks ago


Nanjing, Jiangsu, China DNV Full time
Medical Device Certification Role

This position is responsible for medical device certification, focusing on achieving key performance indicators (KPIs) and efficiently implementing ISO13485 & MDR auditing and assessment work for clients based on CE Directives, International standards, and other applicable Regulatory Systems.

Main Responsibilities:
  • Implement auditing and assessment work for clients with absolute independence and integrity.
  • Contribute to the ongoing improvement of operational efficiency and effectiveness by identifying and pursuing audit process improvements.
  • Organize and deliver projects, assessments, gap analyses, training, and customer workshops.
  • Maintain assessor/auditor registration with DNV and other relevant authorities to work as a Lead Auditor.
  • Perform other tasks assigned by the line Manager.
Requirements:
  • Relevant bachelor's or higher degree in a medical science or medical device area.
  • Minimum 2-4 years' experience in the medical device industry, with 1-2 years in clinical medicine.
  • Auditing experience and registered QMS of CCAA auditor is preferable.
  • High customer focus, good communication and teamwork skills, and fluency in written and spoken English.
Benefits:
  • Flexible work arrangements for better work-life balance.
  • Generous paid leaves, medical benefits, pension and insurance policies, training and development assistance, and additional benefits.

*Benefits may vary based on position, tenure/contract/grade level.*

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age, or political opinion.



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