Regulatory Affairs Specialist

Job Overview

Regulatory Affairs Specialist

Location: Limerick

New, Permanent full time vacancy

The successful candidate will have prior experience in a regulatory environment.

Medical device and / or Pharmaceutical industry experience required.

Job Description

In this role, the Regulatory Affairs Specialist will be working with latest technologies across a broad portfolio of products.

This is a highly visible role within the organisation, and you will participate in cross-functional teams as the regulatory expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program, etc).

Responsibilities

  • Inputs to development of regulatory strategies and provides guidance and expertise.
  • Compiles and communicates regulatory requirements (e.g. MDD / MDR, standards, etc) to cross-functional groups in a concise and precise manner.
  • Prepares and presents gap analysis assessments of regulations and guidance's to peers and cross-functional groups in a concise and precise manner.
  • Reviews and approves the project documentation (design reports, labelling, etc.).
  • Develops tactics supporting first to market commercial opportunities and minimizes time to product launch.

Qualifications and Skills:

  • Relevant 3rd level degree
  • 3+ years' experience in a similar position within a regulatory environment.
  • Experience with regulatory submissions with exposure to programmable electrical equipment desirable.
  • Knowledge and experience on EU MDR / EU MDD and standards (ISO 13485, ISO 14971 and IEC 60601 series…) Knowledge of FDA and international regulatory requirements is a plus.

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