AJL Ophthalmic, a company located in the Alava Technology Park, is looking for a Regulatory Product Specialist.
Description of the position:
The functions that you will have to perfomr will be the following:
- Responsible for the regulatory compliance of a specific range of the medical devices manufactured, through the maintenance and the review of the technical files of the products.
- Coordination and supervision of the clinical and post-marketing trials.
- Collaboration and participation in audits carried out by Notified Bodies under MDR 2017/745 and ISO 13485.
- Management of technical documentation for FDA approval.
We offer indefinite contract and remuneration to be defined depending on the candidates’s worth/experience.
- 1 year experience with medical devices in quality assurance/regulatory affairs.
- MDD/MDR, GMP and ISO regulations.
- Knowledge of FDA regulation.
- High level of English.
- Biomedical engineering
Experience in medical/scienfitic writing is an asset.
Availability to travel.
If you are interested, please send your CV to email@example.com with the subject “Regulatory Product Specialist”.