Description:
- Updating of technical files according to the medical devices regulation (class I, class II A, class II B, custom-made).
- Maintenance of the technical dossiers of medical devices.
- Direct contact with health authorities (AEMPS, Basque Government…), to obtain ISO certification, to validate the update of technical dossiers…
- Bibliographic searches and periodic safety reports (PSUR).
- Contact with production and quality departments.
- Elaboration of safety data sheets for medical devices.
- Coordinate quality control of regulatory documentation, as well as maintaining and updating product tracking databases for planning, scheduling, submissions and action dates, and overall project management.
Requirements:
- Be aware of current regulations and existing changes applicable to our products.
- Perform the analysis of the same, with the essential requirements matrix for knowledge and implementation.
- Work and collaborate with the general management in the implementation and mandatory compliance of the organization.
- Interlocutor with external entities including medical device incidence reporting system and customized medical device.
If interested, please send your resume to andrea.emparanza@atikautomotive.com
About Mizar Health:
Mizar Health offers customized solutions for the healthcare sector through 3D design and the use of additive manufacturing technologies. Its goal is to offer customized solutions that add value to the treatment of each patient.
Mizar Health
Additive manufacturing, Implants, Anatomical models, Surgical equipment, Tailor-made.
