O que eu aprenderei?

The Level 8 Certificate in Medical Technologies Regulatory Affairs and Quality provides students with an introduction to the core elements of the product development lifecycle and the associated role of a Medical Technology Regulatory Affairs and/or Quality professional. The programme ensures that students acquire a good, fundamental understanding of all applicable regulations and skills to address the ever-changing environment of Medical Technologies Regulatory Affairs and Quality.

The Level 8 Certificate in Medical Technology Regulatory Affairs and Quality programme has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by NUI Galway and IT Sligo, in conjunction with external professionals and industry practitioners who have all the required expertise, knowledge, skills and experience to deliver the education and training required to the highest international standards.

The programme aims are to:

  • Provide participants with a fundamental grounding in medical device regulatory and quality requirements.
  • Provide necessary training to convert personnel with life sciences qualifications to transition into specialist roles in medical technology quality assurance and/or regulatory affairs functions and upskill medical technology professionals in the regulatory framework in their existing roles.
  • Foster participants’ intellectual development and develop skills to work and communicate effectively through various media

The Certificate course is also available for students to undertake in a modular format. Students undertaking the modular programme can select any individual module or combination of modules from the six modules in one year. Students must complete all six modules within six years, to obtain a Level 8 certificate award.

The course will enable Regulatory Affairs and Quality Assurance personnel in the Medical Technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of Regulatory Affairs and Quality Assurance. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits.

Further Education

Following completion of the one year Level 8 Certificate in Medical Technology Regulatory Affairs and Quality (30 credits) students are eligible to continue for a second Year to complete a Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality (60 credits). The Higher Diploma award will be available from September 2018.

Graduates with the Higher Diploma award will be eligible to apply to undertake the MSc. in Medical Technologies Regulatory Affairs, a part-time distance learning Level 9 programme jointly delivered by NUI Galway and IT Sligo.

Career Opportunities

This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs environment within the global Medical Technology industry sector. It has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a taskforce comprised of regulatory experts from industry and industry practitioners.

De qual departamento farei parte?

College of Science

Opções de estudo

Online/a distância (1 ano)

Valores
€8.000,00 (R$ 51.084) por ano
Prazo para inscrição

Esperado August 2021

Mais Informações

Data de início

Esperado Novembro 2021

Requisitos de admissão

Para estudantes internacionais

Students with a Level 7 or higher qualification in science or engineering are eligible for this Level 8 programme. Students with a Level 7 or higher qualification in a non-technical subject area but who hold a minimum of two years’ relevant medtech industrial experience in regulatory affairs or quality are also eligible to apply.

English Language Requirements

IELTS: 6.5 overall; Cambridge C1 Advanced (CAE): 176 overall; Cambridge C2 Advanced (CPE): 180 overall; TOEFL: 88; Pearson PTE: 61; Duolingo English Test: 110.

Os requisitos para o IELTS podem variar de acordo com o curso que você escolher.

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