Sana S.

About Sana S.

As a Medical Device Regulatory Specialist based in the UK, my first goal has always been…

Experience

1. Regulatory Specialist- Uk Operations

   Freyr Solutions

   Jan 2010 — Present · GB

   Freyr is a full-service global Regulatory Solutions and Services Company and a specialist provider of Regulatory Consulting, Operations & Technology Services.At Freyr, working as a regulatory expert in the UK, my job role as a UKRP entails the following- Act on a foreign manufacturer’s behalf and registering devices with the MHRA, before they are placed in the UK market- Ensure that all device technical documentation and applicable declaration of conformity documents are in place for the device in scope and that conformity assessment has been completed by the device manufacturer- Maintain copies of the original, amendment and supplements of technical documentation, the declaration of conformity and certificates. These documents should be readily available in case of the MHRA inspections- To present the documents that ensure conformity of the device- To inform the foreign manufacturer immediately about the suspected incidents, complaints and reports received from healthcare professionals, patients and users- To cooperate with the MHRA for any corrective and preventive actions taken for mitigation or elimination of any identified risks posed by the devices- To either maintain samples or have access to the devices, in order to provide to the MHRA, on request. Freyr extends Regulatory expertise to obtain market approvals, registrations, licenses and approvals both globally and locally.