Regulatory Affairs Specialist

Milano Permanente

Pubblicato il 03/08/2021

  • RA Specialist - Medical Device
  • Fluent English and Spanish

Il nostro cliente

For an important multinational company, global leader in Eye Care Device, we are looking for a Regulatory Affairs Specialist. The candidate will plan, organize and manage regulatory activities related to Medical Devices, medicinal products, including notifications, variations, life-cycle maintenance, labeling review and approval, clinical investigations and other studies


Main responsibilities

  • Medical Devices and medicinal products for Italy: ensure products (Medical Devices, Medicinal Products) are marketed according to Business Unit schedule and according to the applicable normative.
  • Anticipate on time with Corporate/Manufacturing plant the required actions in order to start marketing. Maintenance and continuous update of the registration status of the Devices/medicinal products throughout their lifecycle, including: medical device local Health Authority notifications; management of medicinal products variations; management of translations of Medical Device Instructions/Directions for use, Operator Manuals, other pieces of Labelling; management of translations of medicinal products labelling.
  • Keeps updated and informs of the new regulations applicable to Medical Devices and Medicinal products in Spain and in the EU..
  • Regulatory Systems management for devices and medicinal products (including internal and regulatory agencies' data base and electronic applications).
  • Promotional material review and approval; promotional material Health Authority submission.
  • Maintenance and management of internal RA archives.
  • Management of clinical investigations submissions and notifications to Health Authorities.

Il candidato prescelto

  • Health Sciences Graduate Degree (preferably in Pharmacy, Medicine or Biology)
  • At least 3+ years' experience in the role
  • Fluent English and High level of oral and written Spanish

Cosa comprende l'offerta

Ottima opportunità di carriera.

Alessandra Martoglio
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