Medical Technology Regulatory Affairs & Quality

Course Summary
This programme has been designed to meet the growing requirements of Irish 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 selected 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 course will enable Regulatory Affairs and Quality 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. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 60 credits.

Programme objectives are:
• Provide participants with a fundamental grounding in medical device regulatory structures and requirements.

• Provide the training necessary to convert personnel employed in the Medical Technologies sector with life sciences qualifications (Level 6, Level 7, or Level 8) to transition into specialist roles in the medical technology quality assurance and/or regulatory affairs functions and to upskill medical technology professionals in the regulatory framework in their existing roles.

• Foster the participant's intellectual development in academic and industrial environments.

• Develop participant's skills to work and communicate with appropriate autonomy and effectively through various media.

The programme objectives are:
• To produce graduates with the essential breadth and kind of knowledge, skills set and competencies required to function in specialist roles in the medical technology regulatory affairs function, to upskill medical technology professionals in the regulatory framework in their existing roles and to be capable of contribution to regulatory projects and projects with a regulatory element in a medical device company environment.

• To ensure that participants have sufficient skills and knowledge to employ a fundamental level of data analysing, sythesising, summarising and writing skills in a regulatory environment.

• To ensure that participants can communicate and defend scientific data and findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public.

• To ensure participants have the skills and ability to function within, and adapt to, a changing technical work environment and evolving regulatory frameworks.

• To ensure the participants can provide appropriate input and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world.

Course outline
The programme consists of a two year part-time Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality (60 credits). The programme shall be made available online using a combination of distance-learning / e-learning technologies and some face to face workshops for an overall blended learning approach. The educational elements will be provided by the Institute of Technology Sligo, and NUI Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners.

The programme consists of 12 modules, each worth 5 ECTS. The programme is delivered over four semesters (two academic years). Three modules are delivered per semester.

Who teaches this course?
The programme will be delivered by academic staff from NUI Galway and IT Sligo, with expertise in Regulatory Affairs & Quality, with guest lectures and workshops involving Regulatory Affairs/Quality experts from the Medical technology industry sector.

Semester 1
Title Credits
Introduction to Quality Management Systems 05
Fundamentals of EU Medical Device Regulations 05
Auditing and Compliance 05

Semester 2
Title Credits
Fundamentals of US Medical Device Regulations 05
Risk Management and Design Control 05
Validation and Calibration 05

Semester 3
Title Credits
Fundamentals of Global Medical Device Regulations 05
Sterilisation and Biocompatability 05
Operations Management and GMP 05

Semester 4
Title Credits
Fundamentals of Medical Device Clinical Trials 05
Introduction to Market Vigilance and Labelling 05
Technical Report Writing 05

Level 7 qualification in a relevant area of Science, Engineering or Technology.

Applications for online programmes are accepted on the atu sligo website.

All programmes advertised will run subject to sufficient student numbers.

ATU sligo online has two intakes per year, the main one being in September with a smaller listing of programmes for January. For confirmation on start dates check www.itsligo.ie/online

For September, applications open from 1st February each year. Closing date for receipt of applications is 31st august.

For January, applications open from 1st November each year. Closing date for applications is mid-January.

The online application form requires personal details, previous qualifications, professional accreditations, employment history and a personal statement. We recommend collating all the necessary paperwork i.e. Transcripts of previous qualifications, academic certificates before you submit an application.

Once submitted, our admissions team will contact you to confirm eligibility and request copies of any previous qualifications.

Academic staff review every application and approve eligible candidates for the programme.

Admissions team will notify you if you are accepted onto the course and will request deposit to confirm your place.

Places are limited, so please apply early.

Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions.

60

2 years part-time

Delivery Method: Online

On-Campus Attendance
One optional workshop each year which is an opportunity to meet lecturers and network with other students.

Most of our online courses have about 2-3 hours of live lectures per week (but this can vary per programme). The rest of your study time consists of independent learning, communicating with your lecturers and classmates and carrying out assignments.

Live lectures normally take place between 6pm and 10pm, Monday to Thursday but this may vary depending on the availability of specific lecturers. If the Live Classroom scheduled times for the live online lectures do not suit you, recordings will be made available through Moodle and other accessible platforms. These recordings can be downloaded and watched later, at a time that suits you.

Please note, you may be required to take some time off work for the below:

• Exams Christmas Exams: 2 – 4 days in January each year. Summer Exams: 2 – 4 days in May each year.

• Workshops/Practical Classes: Approximately 2 – 4 days per year depending on the course you are studying. You will receive notification of the dates from your lecturer for each specific subject requirement.

During our Online & Flexible Learning Induction, you will meet with your Course Co-ordinator who will be available to answer any questions you might have, and they will give you your timetable for the upcoming academic year.

If you have any further questions, please contact our Admissions Team on admissions@itsligo.ie.

To help balance work, life, and online learning, it is important to understand the time that you will have to dedicate to your studies. This will help you to stay focused, reduce stress, and achieve your goals while also working full-time.

For part-time online or blended learning, it is recommended that you should try to allow for 5-6 hours per week per 5 credit module to your studies.

€4,500 per annum
or €9,000 total.
€900 per module.
Non-EU total fees: €12,000

Next Level Skillnet Member - €1,417.50 per semester*

Fee Next Level Skillnet Non-Member Fee - €2,025 per semester**

* Subject to confirmation of funding support for each semester. See next level skillnet qualifying criteria at http://nextlevel.ie/at-a-glance/employee/
** Companies who do not qualify under the Next Level Skillnet criteria may still enrol on the course at the Non-Member rate by contacting Next Level Skillnet, sue@nextlevel.ie

Contact the college for the next start date.

Career Opportunities
This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs or Quality environment within the highly successful and growing Irish Medical Technology industry sector.

The Level 8 Higher Diploma and 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 in conjunction with a taskforce comprised of regulatory experts from industry, industry practitioners and representatives from the regional skills for a west and north west.

The Irish Medical Devices Association (IMDA) states "The medical technology sector in Ireland is recognised as one of the five global emerging hubs. The sector employs over 29,000 people in Ireland and is the second largest employer of medtech professionals in Europe. Ireland is one of the largest exported of medical products in Europe with annual exports of €12.6 billion and companies here directly export to over 100 countries worldwide. As many as 18 of the world's top 25 medical technology companies have a base in Ireland and 50% of the 450 medtech companies based here are indigenous."

The sector is, by its nature, highly regulated; all disciplines involved in the design, manufacture and distribution of a medical device are controlled by medical device regulations. Given the unique need for regulatory affairs knowledge and understanding at all stages of a medical device product lifecycle there is a strong need for the medical technology industry to have available to it appropriate courses to satisfy this information and skills need. The Forfás National Skills Bulletin 2016 further supports this need as it identified a skills shortage for regulatory professionals and quality control engineers.

Further Study
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 ATU Sligo.