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Medical Regulatory Affairs Executive

Job Title: Medical Regulatory Affairs Executive
Contract Type: Permanent
Location: Galway
Industry:
REF: 90943
Job Published: 7 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 0868395533

Medical Regulatory Affairs Executive
Our client, a medical device company in Galway are currently looking to recruit a Medical Regulatory Affairs Executive for their site.
The successful candidate will prepare and submit medical regulatory dossiers, support and coordinate with customers, inter and intra departmental colleagues and medical Business development managers.

Essential Duties and Responsibilities:
The functions of the Regulatory Affairs Executive include but are not limited to the following tasks:-
  • Compilation of CTD regulatory dossiers Module 1 – 5 for EU National and MRP/DCP Marketing Authorisation (MA) applications
  • Responding to queries raised by the regulatory authorities / customers
  • Maintaining regulatory information on database
  • Artwork review and approval
  • High level review of process validation protocols and reports for inclusion in Module 3.
  • High level review of assay validation data and stability data to be included in Module 3
  • Transfer of data from Regulatory Department to other departments & external partners
  • Working with Qualified Persons Responsible for Pharmacovigilance (QPPV’s) in line with EU & In-house pharmacovigilance procedures and practices.
  • Supporting other departments and external partners
Person Specification:
  • Good communication skills (written and orally), with the ability to work in a busy environment and on multiple projects simultaneously to tight deadlines.
  • Scientific qualification and background, preferably B.Sc. or equivalent.
  • Prior experience in regulatory/R&D/Quality environment, preferably with experience in generic applications.
  • Good technical knowledge, good attention to detail and good IT skills in Word and Excel are essential.
  • Strong Customer Service focus is key to this role
For further information on this Medical Regulatory Affairs Executive role in Galway please contact Bimi Felix on 0868395533 / bimi@hero.ie
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