The Higher Diploma Medical Technology Regulatory Affairs Professional will be delivered and accredited through GMIT.

The programme is a 60 credit NFQ Level 8 award is based on the need to provide a skilled workforce to implement and support the medical device sector with the new Medical Device Regulation (MDR) coming into effect in May 2021 and the in vitro Diagnostic Device Regulation (IVDR) implementation due in 2022.

The course participants must have at least a level 8 qualification, or equivalent work experience, prior to acceptance onto this course.  It is suitable for participants intending to work in regulatory affairs roles.

The course will:

  • Provide a practical solution for participants to gain practical & theoretical understanding of regulatory affairs activities for the Medical Technology sector.
  • Support Medtech industry by ensuring that students are well informed and educated in-depth on the specific regulations and associated application
  • Provide a programme of ongoing assessment with course advancement linked to achieved results.
  • Incorporate practical industry experience will ensure that students can immediately apply knowledge and competence.
  • This will include a blended learning approach with 10 contact hours on a weekly basis over 3 semesters resulting in 60 ects.

As an introduction; the current module Fundamentals of Regulatory affairs will be provided such that those that have already achieved this course can get an exemption. It is intended to provide a qualification for graduates (employed/unemployed) to undertake a career in Medical Technology Regulatory Affairs to meet the clear need to upskill/hire personnel to the regulatory affairs function. In addition, participants who want to aspire to management level within the Regulatory Affairs profession can further develop their skills offer with immediate value to the business on programme completion.

Modules

  1. Fundamentals in Regulatory Affairs: Fundamentals in Regulatory Affairs
  2. Quality Management & Technical Writing: Quality Management & Technical Writing
  3. Clinical Evaluation Masterclass Series: Clinical Evaluation Masterclass Series
  4. Design & Device Evaluation: Design & Device Evaluation
  5. U.S. Regulations: U.S. Regulations
  6. EU Regulations & Mutual Recognition agreements: EU Regulations & Mutual Recognition agreements
  7. EU Regulations & Mutual Recognition agreements: EU Regulations & Mutual Recognition agreements
  8. Global Regulations & MDSAP: Global Regulations & MDSAP
  9. Post Market Responsibilities incl. EUDAMED: Post Market Responsibilities incl. EUDAMED
  10. Regulatory Affairs Business Strategy: Regulatory Affairs Business Strategy

Entry requirements for applicants

Participants must have at least a level 8 qualification, or equivalent work experience, prior to acceptance onto this course.

All employed participants will be required to pay 10% of the overall costs of the programme. 10% cost is €690.00 per person.

The following documents must be attached to your application; (Whichever document is relevant to your status)

  1. If you are employed – a letter from your employer / P60 confirming you are employed.
  2. If you are a homemaker you need to have a letter confirming this, signed by commissioner of oath.
  3. If you are unemployed you need to send a copy of your job seeker benefit/allowance slip, or a letter from your social welfare office.
  4. Copy of transcripts to support your academic history.
  5. CV.

Eligibility criteria

To confirm eligibility on Springboard courses, please go to https://springboardcourses.ie/eligibility

Apply

Click here to apply online at springboardcourses.ie