SGS Verified 11h ago
Global Team Leader - IVDR
Warszawa, Województwo mazowieckie, Poland Remote
Salary not listedPaySalary not listed
TypeFull-time
Work settingRemote
Verified listing
JobFig found this opening at its original source and checks that it remains available.
About the role
The position reports to the Head of Delivery & Operations
What you'll bring
- Extensive working knowledge of (in vitro diagnostic) medical device management systems, in vitro diagnostic medical device compliance and auditing and technical documentation assessment techniques.
- Effective interpersonal skills, able to develop good working relationships with medical device teams and delivering office colleagues.
- Appropriate knowledge and understanding of devices legislation as well as harmonised standards, CS and guidance documents.
- Appropriate knowledge and understanding of the conformity assessment procedures provided for in the regulations for medical devices.
- Knowledge and experience with the NB’s quality management system, related procedures and the required qualification criteria.
- The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
- Successful completion of a university or technical college degree or equivalent qualification in relevant studies e.g. Microbiology, medicine, pharmacy, engineering or other relevant sciences.
- Experience of management of cross functional global teams is an asset.
- Broad range of competency codes.
- Understanding of the clinical application of the technology.