Senior Regulatory Affairs Specialist

07 Nov 2017
13 Dec 2017
Contract Type
Full Time
Real Staffing have been retained exclusively to represent our client who are a global leader in their field, developing and manufacturing an extensive portfolio of products spanning Medical Devices and Pharmaceutical industries.

The company who are recognised as innovation leaders, are adding a Regulatory Affairs Senior Specialist who is willing and able to take a handson approach to their work in a fast moving, high volume manufacturing environment to their team based in Northern Ireland.

It is imperative that you have experience with both the EU and USA regulatory requirements for Medical Devices and/or Pharmaceutical products but ideally both as some of their new and existing products are regulated as Devices in Europe and as Pharmaceuticals in the USA market.

The Regulatory Affairs Senior Specialist will report into the Regional Head of Regulatory Affairs (EMEA). They will also manage one pharmacovigilance report and will ideally have the capability to manage the pharmacovigilance activities, potentially through a 3
rd party.

The Senior Specialist will be the most senior Regulatory Affairs team member on site and will act as the Subject Matter Expert, dealing with numerous internal teams such as Quality, Commercial and R&D, as well the global regulatory team and external regulatory bodies such as the MHRA.

If this opportunity sounds like it could align with your career aspirations, please contact Lillie FenlonBillson on l.fenlonbillson at ######.###

Sthree UK is acting as an Employment Agency in relation to this vacancy. Advertised through Zoek ab75d95f17f7488b8aa9ca2ee957cc0813