Job Overview

CrannMed is based in Galway and was founded in 2018. The Company is focused on the development of a range of peripheral devices.  We currently have a team of 17 people and recently moved into new offices in Galway Technology Park, Parkmore, Galway.

CrannMed are seeking a career focused and motivated Design Assurance and Regulatory Affairs Specialist to work with us through the next stages of our growth. The ideal candidate must be adaptable, resourceful, motivated, with good attention to detail and a desire to learn. The successful candidate will report to the QA/RA Director.

Main Responsibilities

  • Apply technical solutions to quality projects
  • Use technical writing skills to compile Regulatory submission and Design Reviews
  • Understand standards and their application to medical devices
  • Planning, protocol and report generation for development of medical devices
  • Generation and maintenance of regulatory files for medical devices
  • Review and update design & regulatory files in line with regulatory requirements
  • Ensuring that records are filed in accordance with company procedures
  • Supporting R&D with Design Control
  • Support Quality System processes
  • Analyze customer complaints, identify trends and execute corrective actions
  • Performs other related duties and tasks, as required

Characteristics Required

  • Technically orientated, with a proven problem solving mindset.
  • Desire to learn through investigation and practical trials.
  • An ability to conceptualise and develop new processes
  • An interest in engaging with vendors, physicians, suppliers and other partners to iterate and develop solutions.
  • Self-motivated, Adaptable and Responsible, with a strong work ethic.
  • Excellent organisational & communication skills (written and verbal).

Background & Qualifications:

  • Bachelor’s degree or higher in Engineering / Science qualification
  • Must have 5+ years’ experience working in the Medical Device industry
  • Good communication skills. Both verbal and written – English. 
  • 2/3 years’ experience in Risk/ Design Control or Regulatory filing an advantage

Apply via email to Applications close on January 14, 2022.