Program Overview

Regulatory Affairs in Medical Devices (Certificate, L9, 20 ECTS)

Course Overview

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 programme 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.

Entry Requirements

• A minimum honours bachelor degree (Level 8) in any discipline with a minimum of two years, relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.
• A minimum ordinary bachelor degree (Level 7) in any discipline with a minimum of three years relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.
• 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.

Course Content

Semester 1

• Regulatory Affairs (Medical)
  • 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.

Semester 2

• Advanced Regulatory Affairs (Medical)
  • 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.

Career Opportunities

• 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.

Delivery

• Modules are to be delivered over one year in an online learning format.
• The indicative schedule for delivery is subject to change.
• 4 hours per week
• Number of Weeks: 12 per semester
• Number of Days / Evenings per week: 2
• Number of Hours per week: 4
• Delivery Day / Evening: see below
• Semester 1: September – December / Wed 7-10pm / Fri 2-3pm
• Semester 2: January – April / Wed 7-10pm / Fri 2-3pm

Time Commitment

• 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.

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, i.e., NO terminal examinations.

Qualification

• Certificate in Regulatory Affairs in Medical Devices (Special Purpose Award, Level 9, 20 ECTS)

Fees

• €2,800

Application Deadline

• TBC for 2025

Places are allocated on a first-come, first-served basis, prioritizing unemployed and returning applicants.

Course will be closed once the maximum number of applicants is reached.

Courses run subject to viable numbers.