Regulatory Specialist - Galway

Ref: 232 Date Posted: Monday 18 Sep 2023

Regulatory Specialist

The position of Regulatory Specialist will be responsible to provide technical and administrative regulatory support to ensure maintenance of my clients Quality System Compliance, maintenance of existing products and timely introduction of new products subject to medical device regulations in both the E.U., U.S. and global regions. 

Job Functions:

  • Assist in preparing applications to the Regulatory Body for global certification submissions. 
  • Prepare required documentation for Technical Documentation submissions per MDR 2017/745 requirements and documentation as needed for change management rationales and international change notifications. 
  • Prepare required documentation for Technical File submissions per FDA requirements and documentation as needed for change management rationales and international change notifications. 
  • Review of Regulatory requirements and guidelines as required.
  • Assist with the Customer complaints process, Adverse Event reporting disposition and prepare relevant documentation to support the adverse event reporting process.
  • Assist with risk management activities within the client site.
  • Assist and coordinate review of regulation submissions and test protocols with Management. 
  • Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions. 
  • Assist the Product Development team to ensure that all aspects of Design Transfer activities are being met.
  • Assist with the onboarding of new distributors, per MDR 2017/745
  • May be required to carry out internal audits, as necessary.
  • Ensuring that the regulatory processes needed for the QMS are documented.
  • Reporting to management on the effectiveness of the QMS and any need for improvement
  • Ensuring the promotion of awareness of applicable regulatory requirements and quality management systems throughout the organization.
  • Other activities as business needs arise.


Bachelor of Science required (or equivalent), with emphasis on life science or engineering. 

Minimum of five years knowledge and experience with quality and regulatory requirements for medical devices mainly: MDR 2017/745 CE mark technical files; 13485:2016, 14971:2019, 62366-1, US FDA CFR 820, Pre-Submissions, 510(k)'s, and design dossiers.