L8 Certificate in Science in Medical Technologies Regulatory Affairs & Quality (September 2019)

Institute of Technology, Sligo (SG_MEDI_E08)
Key Programme Details
Award

Certificate

NFQ Level

8 About NFQ

Delivery Method

Online

Mode

Part Time

ECTS Credits

40

Department

Life Science

General Information
Contact

Jean Gilligan

Email

gilligan.jean@itsligo.ie

Phone

071 9305835

Address

Jean Gilligan,
Springboard Project Coordinator,
IT Sligo,
Ash Lane,
Sligo.

Role

Springboard Project Coordinator

Important Dates
Application Deadline

19/07/2019

Start Date

16/09/2019

End Date

29/05/2020

About this Course

An IMDA publication (May 2017) examined the skills requirements of the Med-tech sector in Ireland and outlined a potential 4,000 jobs up to 2020. Analysis as part of the publication identified skill shortages arising in many areas of MedTech but in particular, there are shortages of qualified personnel in regulatory roles. The impetus for the development of this specialist programme emerged from industry needs and content has been developed in conjunction with a taskforce comprising regional skills for a (Northwest and west) and MedTech companies such as Boston Scientific and Siemens amongst others. The design and development of the programme will be based on the consortium partners experience and track record in the development of similar programmes designed to meet industry needs. We have an ongoing programme in this area at Level 9, which was designed and developed with substantial consultation with the IMA stakeholders, including MedTech industry representatives, and professionals involved in regulatory affairs within the sector. The academic partners associated with this programme have been engaged in very active discussions over the last year in relation to the planned rollout of a joint IT Sligo / NUI Galway and Next Level Skillnet Level 8 programme in Regulatory Affairs and Quality. These partners have been working together since early 2015 on the Level 9 programme and Next Level Skillnet became involved in early 2017. There is currently no equivalent programme on offer at Level 8.

Brief Statement of Aims and Objectives:
The course is intended to increase the skills and knowledge base of those with activities or interest in regulatory affairs and quality systems and to increase the pool of such people available to the medical device industry. It will provide a level 8 qualification in regulatory affairs/Quality that will form both an introduction for new or proposed entrants to the area and additional skills and knowledge to those working in the area. The Level 8 programme in Medical Technology Regulatory Affairs and Quality aims to support national development in economic, social and cultural terms and furthermore to deliver training which is customised to meet the exact needs of the clients.

The programme aims are to:
· 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.

PROGRAMME OBJECTIVES
· 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

Objectives

The course is intended to increase the skills and knowledge base of those with activities or interest in regulatory affairs and quality systems and to increase the pool of such people available to the medical device industry. It will provide a level 8 qualification in regulatory affairs/Quality that will form both an introduction for new or proposed entrants to the area and additional skills and knowledge to those working in the area.
The Level 8 programme in Medical Technology Regulatory Affairs and Quality aims to support national development in economic, social and cultural terms and furthermore to deliver training which is customised to meet the exact needs of the clients.

Entry Requirements

Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme. Applications from candidate who hold a Level 7 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and / or regulatory affairs will be considered. Candidate interviews may be used to assess candidate’s suitability for the programme.

Long Description

An IMDA publication (May 2017) examined the skills requirements of the Med-tech sector in Ireland and outlined a potential 4,000 jobs up to 2020. Analysis as part of the publication identified skill shortages arising in many areas of MedTech but in particular, there are shortages of qualified personnel in regulatory roles. The impetus for the development of this specialist programme emerged from industry needs and content has been developed in conjunction with a taskforce comprising regional skills for a (Northwest and west) and MedTech companies such as Boston Scientific and Siemens amongst others. The design and development of the programme will be based on the consortium partners experience and track record in the development of similar programmes designed to meet industry needs. We have an ongoing programme in this area at Level 9, which was designed and developed with substantial consultation with the IMA stakeholders, including MedTech industry representatives, and professionals involved in regulatory affairs within the sector. The academic partners associated with this programme have been engaged in very active discussions over the last year in relation to the planned rollout of a joint IT Sligo / NUI Galway and Next Level Skillnet Level 8 programme in Regulatory Affairs and Quality. These partners have been working together since early 2015 on the Level 9 programme and Next Level Skillnet became involved in early 2017. There is currently no equivalent programme on offer at Level 8.
Brief Statement of Aims and Objectives: The course is intended to increase the skills and knowledge base of those with activities or interest in regulatory affairs and quality systems and to increase the pool of such people available to the medical device industry. It will provide a level 8 qualification in regulatory affairs/Quality that will form both an introduction for new or proposed entrants to the area and additional skills and knowledge to those working in the area. The Level 8 programme in Medical Technology Regulatory Affairs and Quality aims to support national development in economic, social and cultural terms and furthermore to deliver training which is customised to meet the exact needs of the clients.

The programme aims are to:
· 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.

PROGRAMME OBJECTIVES
· 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

For all IT Sligo Springboard programmes, the participants will be enrolled on a mandatory and accredited ‘Personal Effectiveness and Employability’ programme that will be delivered by distance learning using an enquiry based and interactive learning approach. These programmes are designed to improve the employability skills of the students with particular emphasis on CV and Interview preparation and on the job transferable skills to become an effective team member. These modules will also outline the skills needed for effective engagement in the workplace.
The ‘Personal Effectiveness and Employability’ programme has been assigned 10 credits and on completion of this module the learner will be able to develop an independent, self-managed, reflective approach to study and work. They will become familiar with workplace cultures and collaborate effectively in groups, teams and meetings.

Why Choose This Course

The course is intended to increase the skills and knowledge base of those with activities or interest in regulatory affairs and quality systems and to increase the pool of such people available to the medical device industry. It will provide a level 8 qualification in regulatory affairs/Quality that will form both an introduction for new or proposed entrants to the area and additional skills and knowledge to those working in the area.

The programme objectives include:
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 up skill 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,
synthesising, 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.

IT Sligo Springboard participants can avail of the services of the Careers office and the IT Careers Portal. The Careers officer provides guidance to students regarding their programme of study and career options. A virtual and campus based career fair occurs annually and students have access to employers and their current requirements. Students can attend live events where they can visit live interactive sessions with employers.
Students also have access to a postgraduate fair, which also occurs annually on campus. As part of this event, students will have an opportunity to attend CV Clinics and have their CV professionally checked by HR professionals. They can also attend seminars and lectures relating to career development, identifying target employers, how to connect with employers, collaborate effectively in groups and in identifying and applying on the job soft skills.
IT Sligo delivers a 'Personal effectiveness and employability' programme which is designed to enhance participants job readiness training. This is a 10 credit module and it has been designed to enhance the skills needed for effective engagement in the work place.
IT Sligo also helps students get ahead in the world of work with an industry placement. Thanks to our close contacts and research collaborations with many companies and major employers, we can offer a wide variety of opportunities in destinations across the region and beyond.

Career Opportunities

The Level 8 programme in Medical Technology Regulatory Affairs and Quality aims to support national development in economic, social and cultural terms and furthermore to deliver training which is customised to meet the exact needs of the clients.

The programme aims are to:
· 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 up skill 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.

Timetable Info

Lectures delivered online in the evenings and also available to download as recordings. The schedule will be confirmed in September.

Delivery Location

IT Sligo online delivery

Delivery Notes

Online learning

Admissions Contact Details
Contact Person

Admissions Office IT Sligo

Address

Online Admissions,
IT Sligo,
Ash Lane,
Sligo.

Phone

0719318511

Email

springboardadmissions@itsligo.ie

RPL Information

IT Sligo recognises and assess prior experiential learning of applicants through its RPL process. The institute is committed to maximising access and flexibility to applicants and the RPL procedure outlines how a learner may apply for and obtain credits for prior learning. The definition of credit in this instance is the award of a grade for learning in the context of the relevant course schedule.

Application Procedures

Apply online through the Springboard website www.springboardcourses.ie

Media
IT Sligo Online

Experience online learning at IT Sligo

https://www.dropbox.com/sh/2ytk4szuvg6opxm/AABKwO9YnAT9ErMeEpJVGlI5a?dl=0


Online learning webinar

The webinar demonstrated the medium by which online programmes are delivered at IT Sligo

https://drive.google.com/file/d/0B6R5gsxoeXRZQnplMGRfdGVpWG8/view?usp=sharing


IT Sligo Website

Programme page Level 8 Certificate in Medical Technologies Regulatory Affairs and Quality

https://www.itsligo.ie/courses/certificate-medical-technology-regulatory-affairs-quality-online/