Senior Regulatory Affairs Specialist

My client are a medical device organisation and are seeking to take on a Senior Regulatory Affairs Specialist on a permanent basis.

They're located in the heart of Galway, where their centre of excellence is.

They have a reputation for introducing and marketing innovative, high-quality products designed to enhance the practice of interventional medicine. They've been in Galway over 20 years and have employ 800 people here, and you could be the next to join them!

What will I be doing as a senior regulatory Affairs Specialist?

  • Determines regulatory pathways for various projects including product classification and subsequent regulatory submission to Regulatory agency/Distributor as required.
  • Construction of Technical Files and associated documentation and/ or regulatory rationales.
  • Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
  • Interacts with various levels of management, external agencies and companies.
  • Analyzes and makes recommendations regarding field complaints.
  • Remains current on developing regulations and revision of systems for continued compliance.
  • Participates in and assists with facility inspections, Notified Body Audits, TGA and other inspections/ audits as required.
  • Assists with supervision of department staff, as required.
  • Performs other related duties and tasks, as required.

What I need to be a Senior Regulatory Affairs Specialist?

  • Education and experience equivalent to a Bachelor's Degree in a technical field such as the biological, physical, engineering or material science disciplines and four years of related industry experience.
  • Demonstrated knowledge of the Medical Devices Directive (Preferable) (93/42/EEC, as amended), U.S. FDA regulations and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
  • Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
  • Self-motivated, self-directing, strong attention to detail and excellent time management skills.
  • Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others.

Don't miss out on this great opportunity to join this team, to apply send an up to date CV.

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Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales