Regulatory Product Specialist

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.
 

Candidate profile:

Knowledge/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.

Education:

• • Biomedical engineering
  • Pharmacy
  • Biology
  • Biochemistry
  • Similar

Experience in medical/scienfitic writing is an asset.

 

Comments:

Availability to travel.

 

If you are interested, please send your CV to evalarra@ajlsa.com with the subject “Regulatory Product Specialist”.