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Regulatory Affairs in Medical Devices (L9, 20 ECTS)

Status: OPEN


Level

09

Duration

9 Months

Department

Mechanical & Automobile Engineering


Start Date

12/09/2022

Course Type

Flexible & Professional

Location

Online

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 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

Who can I contact?

What modules will I study?

Semester 1: September - December  - 2022

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: January - May - 2023

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.

**Times subject to change. TBC

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.

More Information

Delivery

This programme will run 100% online from September 2022 to May 2023. 3 hours per week.

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

Materials –  Available in our online library for all TUS students.

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.

Assessment 

Students will be assessed on their learning by a variety of strategies including:

  • The use of continuous assessment through projects, coursework, multiple choice questions, etivities, presentations and assignments. 100% continuous assessment ie. NO terminal examinations.

Qualification

Certificate in Regulatory Affairs in Medical Devices (Level 9, 20 ECTS)

For queries relating to the course 

Contact: Department of Flexible Learning

TUS Moylish.

Email: Flexible@lit.ie 

Academic Queries

Email: Clodagh.Moore@lit.ie

Application Deadline

17 July 2022

Course Fees

€2,500

Click here for all Flexible Learning Policies & Procedures