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Regulatory and Quality Specialist | Remote

***Regulatory and Quality Specialist | Remote***

We are truly excited to be working with an Irish start-up which has developed the world’s first digital solution for therapy of several common conditions that have a serious negative impact on human lives. This cutting-edge solution delivers an improved patient experience, increases accessibility and improves the clinician productivity while also reducing waiting lists. The team is currently small, experienced and highly ambitious, creating an enjoyable and dynamic work environment. Would you like to be a part of something that will significantly change the quality of millions of lives? Do you have experience in engaging with auditors and consider yourself a great communicator?

Role Overview

The company is seeking a Regulatory and Quality Lead to build the quality infrastructure. It is expected that over time this role will grow in terms of leadership potential. This is an exciting opportunity to make a real difference at the early stages of a startup and to help transform the delivery of care in this critical part of the healthcare industry.

Role Responsibilities

  • Define the Regulatory and Quality requirements

  • Be the person responsible for regulatory compliance

  • Create a Regulatory and Quality Strategy for the company for all target regions

  • Drive and Refine the QMS

  • Drive vendor engagement quality requirements

  • Define the quality requirements for the customer support operation

Experience and Skills:

  • Science or engineering degree

  • At least 3 years’ experience of responsibility for a portion of medical device quality and/or regulatory matters, so qualified to be a PRRC.

  • Familiarity with ISO13485 and EU MDR requirements.

  • Evidence of being a self-starter and managing own projects

  • Have written QMS procedures and experienced presenting for Notified Body audits

  • Qualified Internal Auditor to ISO13485 advantageous but not essential.

  • Familiarity with US HIPAA requirements

  • Experience of working in a start-up environment

For a confidential discussion and more information on the role, please contact Aisling Lane.

(021) 4320675