DescriptionJob Description :
Start your career in Hamburg with in an exiting, challenging and emerging area of quality management and regulatory affairs combined with a highly complex technical assessment on the design, safety and performance of medical devices!
The working student medical devices supports the Operational Department in maintaining certification data in several databases including EUDAMED. He/she will also support Lead Auditors and Experts by developing and maintaining documents needed for the conformity assessment of medical devices. The student will work closely with all operational departments to ensure precise and consistent documentation and to maintain a reliable information flow.
Key tasks of the working student medical devices:
- Maintaining certification data in several databases including the European Database for Medical Devices - EUDAMED.
- Supporting Lead Auditors or Experts concerning Submission File Preparation, Record keeping and Completeness checks
- Developing and maintaining documents needed for the conformity assessment of medical devices while applying internal procedures.
- Supporting other areas within the organization as needed
- Executing special projects (to be specified by the Head of Operations or Certification)
Position Qualifications and personal skills:
- Studying a technical course of studies (ideally medical technology) or any other life science background, preferably in the Hamburg Area
- We hire for mindset! Self-organized Teamplayer with problem solving attitude and ability to manage multiple tasks simultaneously in a structured manner
- Interest in Regulatory Affairs of Medical Devices, e.g. MDR or ISO 13485.
- Interest in Medical Devices and associated business and/or certification processes
- Ability and interest to work within an IT environment
- Good Language skills in German and English
Responsibilities
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. Diversity is fundamental to our culture and we invite you to be part of this diversity.
DNV is a proud equal-opportunity employer committed to building an inclusive and diverse workforce. All employment is decided on the basis of qualifications, merit, or business need, without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. DNV is committed to ensuring equal employment opportunity, including providing reasonable accommodations to individuals with a disability. US applicants with a physical or mental disability who require a reasonable accommodation for any part of the application or hiring process may contact the North America Recruitment Department (hrrecruitment.northamerica@dnv.com). Information received relating to accommodations will be addressed confidentially.