Regulatory Affairs in Medical Devices - Online

Regulatory Affairs in Medical Devices (L9, 20 ECTS)
This programme in Medical Device Regulations aims to provide learners with a fundamental understanding of EU ,USA and Other Jurisdictions regulatory systems in the medical device field. The programme will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to medical devices in the world market. This programme will explore theory, regulations, tools and techniques used in these companies. As well as giving learners competence in the appropriate legal, compliance and operational standards in industry. Critical thinking, problem solving, decision making, professionalism and management techniques will be key areas covered by the programme. This programmes will enhance a learners career in regulatory affairs by developing increasing levels of competence and professionalism by obtain a formal qualification in the medical device regulation industry.

This Graduate Certificate of Science is delivered on line and designed as part of an innovative multi- tiered programme to address the needs and requirements of industry-based learners and making education more accessible. It is designed so that learners can opt to select the module streams individually as Special Purpose Awards, complete three of the module streams to attain a Level 9 Graduate Diploma or opt for the Level 9 Masters of Science.

The course will provide students with critical thinking, problem solving, decision making, professionalism and management techniques will be key areas covered by the programme.

What will the time commitment be?
Each 5 credits will normally equate to approximately 100 Total Learning Hours. Total Learning Hours includes the time you spend in class (lectures, tutorials, practical elements) and the time you spend completing work outside of college. The balance between these two varies by discipline, and by level of study. You should bear in mind that the workload will increase at particular times e.g. when assignments are due.

What modules will I study?
Semester 1
Regulatory Affairs (Medical) - Wednesdays 7pm - 10pm*
Provide learners with an understanding of EU regulatory systems in the medical device field.

The programme will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to medical devices in the EU market. This module will explore theory, regulations, tools and techniques used in these companies. As well as giving learners competence in the appropriate legal, compliance and operational standards in industry. This module will enhance a learner's career in regulatory affairs by developing increasing levels of competence and professionalism by obtaining a formal qualification in the medical device regulation industry.

Semester 2:
Advanced Regulatory Affairs (Medical) - Wednesdays 7pm - 10pm*
Understanding of the utilisation of standards, FDA and other jurisdictions' guidance documents and technical writing. The module will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to medical devices in the world market.

What are the entry requirements?
(a) A minimum honours bachelor degree (Level 8) in any discipline with minimum two years, relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning

Or

(b) A minimum ordinary bachelor degree (Level 7) in any discipline with minimum three years relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning

Or

(c) Equivalent Qualifications. Applicants with equivalent qualifications on the European and International frameworks will also be considered. International students must evidence a proficiency in English language for example IELTS 6.0.

Application Deadline: TBC for 2023
Register Your Interest for September 2023: https://lit.ie/Register-Your-Interest?coursecode=LC_ERAMP_ROL

9 months.

Delivery
Lectures will be delivered 100% online via Moodle/MSTeams. Lectures will be recorded and available to watch back.

Number of Weeks: 12 weeks per semester
Number of Days/Evenings per week: One

Delivery Day/Evening: Semester 1&2 Wednesday (subject to change).
Number of Hours per day/evening: 3 hours
Times: 7:00pm to 10:00pm*

**Times subject to change. TBC

Are there opportunities for further study?
Students can transfer on to either of:
1. Graduate Diploma in Process Validation and Regulatory Affairs in Medical Devices
2. Masters of Science in Process Validation and Regulatory Affairs
3. Graduate Diploma in Process Validation and Regulatory Affairs in Pharmaceutics
4. Graduate Diploma in Process Validation and Regulatory Affairs in Food and Drink

What are the career prospects?
There are multiple roles a graduate from the programme can seek in areas such as Regulatory Engineer, Quality Engineers, Regulatory Affairs Management, Process Engineering Management, Compliance and Regulatory Management, Risk Management etc.

International Opportunities offered by Programme:
The content of the modules will be seen to reflect a globalised environment .This is demonstrated by the regulatory affairs module stream which focuses on EU, US and worldwide regulatory affair bodies.