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

  • Status: Register Your Interest

  • Campus: Online

  • years: 1

  • Fees: €2,800


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 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.

Contact Details

General Queries

Flexible Learning Office

Email: flexible.midwest@tus.ie

Telephone: (061) 293802

Academic Queries

Clodagh Moore

Email: Clodagh.Moore@tus.ie

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.

or

Recognised Prior Learning (RPL): Prospective applicants who do not meet the academic entry requirements should submit their application online and then email Flexible.midwest@tus.ie to request assessment via RPL.

ENGLISH LANGUAGE: Applicants who do not have English as their first language must ensure they satisfy English Language requirements. For entry to undergraduate courses, a score of 5.5 in an IELTS or equivalent exam is required. For postgraduate courses, a score of 6.0 in an IELTS or equivalent exam is required. It is the responsibility of the applicant to ensure their English proficiency meets these requirements.

Course Content

  • 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. 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.

  • 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.

More Information

  • 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.

  • Modules are to be delivered over one year in an online learning format.

  • 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.

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

  • €2,800

  • TBC for 2024-2025 Academic Year