• Ross University School of Veterinary Medicine Featured Masters Courses
  • University of Leeds Featured Masters Courses
  • Swansea University Featured Masters Courses
  • Xi’an Jiaotong-Liverpool University Featured Masters Courses
  • Birkbeck, University of London Featured Masters Courses
  • Goldsmiths, University of London Featured Masters Courses
  • University of Cambridge Featured Masters Courses
  • Ulster University Featured Masters Courses
De Montfort University Featured Masters Courses
Sheffield Hallam University Featured Masters Courses
University of Leeds Featured Masters Courses
Xi’an Jiaotong-Liverpool University Featured Masters Courses
De Montfort University Featured Masters Courses

Medical Technology Regulatory Affairs (MSc/PgDip/PgCert)


Course Description

Course Description

Regulatory affairs professionals play an important part in coordinating scientific endeavour with regulatory demands throughout the life of a medical device product from design conception through manufacture to market.
This part-time executive course provides professionals working in medical device regulatory affairs with a recognised way of formalising your skills, whilst retaining in employment with the flexibility to fit around your current job and responsibilities.

Overview

In today’s competitive and highly regulated healthcare environment, it is essential for companies to bring new products to the market quickly – and to keep them on the market. Excellence in managing regulatory issues is therefore a key strategic advantage to healthcare companies.

Regulatory affairs professionals play an important part in coordinating scientific endeavour with regulatory demands throughout the life of a product.

Available on a part-time basis only, this qualification is designed to be flexible in order to fit around your current job and responsibilities. For even greater flexibility the course is also available at Diploma and Certificate level. For professionals with a specific interest, individual modules may be attended as standalone short courses without the need to register for the full qualification.

English Language Requirements

If you are an international student you will need to provide evidence that you have achieved a satisfactory test result in an English qualification. The minimum standard expected from a number of accepted courses are as follows:

IELTS - 6.5
TOEFL - 92
Pearson PTE Academic - 65
Cambridge English Scale - 180
Cambridge English: Advanced - C
Cambridge English: Proficiency - C

In addition to these minimum scores you are also expected to achieve a balanced score across all elements of the test. We reserve the right to reject any test score if any one element of the test score is too low.

We can only accept tests taken within two years of your registration date (with the exception of Cambridge English tests which have no expiry date).

Structure

This part-time Medical Technology Regulatory Affairs MSc course provides working professionals with the opportunity to obtain a formal qualification in the Medical Device Regulation industry. The programme is specifically designed for professionals to help support you to fit study into your working life. Modules are condensed as we appreciate securing time away from the office is challenging and off campus support is available via online facilities and personal tutor support via email and telephone.

This MSc presents a broad view of the regulatory affairs role and provides a detailed insight into current and proposed EU legislation.

With this formal qualification, skills will be easier to demonstrate to employers and peers. Employers will benefit through the development of personnel to an increased level of competence and professionalism whilst those involved in recruiting will find it easier to identify proficiency using this gold standard.

The programme will also help you develop a set of transferable skills that will directly meet the requirements of your current or future employer including information technology, written and verbal communications skills, team working, independent research skills, data analysis and critical thinking.

Medical Technology Regulatory Affairs MSc is made up of three components:
- A formal taught component comprising eight modules
- Core Principles Integration - Integrating Portfolio
- Individual Research Project

Core Modules

The formal taught component of this course comprises eight modules covering everything from the main principles of regulatory affairs to regulatory strategies used when taking new products to market. This element constitutes 40% of the overall mark and the marks for each of the modules are obtained through a combination of different written assignments.

Each module is delivered over three days in our dedicated postgraduate teaching facilities at Cranfield University and a maximum of four modules can be studied each year.

For those students who do not wish to complete the full MSc course a Diploma and Certificate level is also available. The Diploma includes eight modules and an integrating portfolio. The Certificate includes six modules.

For even greater flexibility individual modules can be attended as standalone three-day short courses. Please enquire for more details.

Cranfield University campus has excellent transport links and several hotels and accommodation options on site making it a very easy place to attend modules.

Core:
- Principles of European Medical Technology Regulatory Affairs (RA)
- Design, Development and Testing of Medical Devices
- Clinical Evaluation of Medical Devices
- Strategic Management of Regulatory Affairs
- Medical Technology Vigilance, Post-Market Surveillance and Risk Management
- US Regulation of Medical Technology
- Regulatory Strategy through the product lifecycle
- Medical Technology Vigilance, Post-Market Surveillance and Risk Management

Core Principles Integration

A critical part of the course, the integrating portfolio enables you to effectively apply the theory you have gained from the taught elements of the course to your workplace. This element constitutes 20% of the overall mark

Individual Project

The individual research project is an integral part of the course. It gives you the chance to apply the skills, knowledge and understanding acquired during the taught phase of the course to a practical problem in regulatory affairs.

The research project will most likely be undertaken in your place of work - benefiting both you and your employer. However you may be able to complete this at Cranfield or possibly at another organisation and we may be able to help you find placements. This element constitutes 40% of the overall mark.

Assessment

Modules – combination of written assignments. Core Principles Integration element - written assessment. Individual Research Project - combination of a submitted thesis and oral presentation. The pass mark for all components is 50%.

Career opportunities

The Medical Technology Regulatory Affairs MSc provides graduate professionals working in healthcare regulatory affairs – who have already gained first-hand practical experience of handling regulatory issues – with an advanced theoretical understanding of the processes and practices central to medical device regulatory affairs.

Several of our past students have moved into regulatory roles or been promoted within their organisations.

In addition, our course will help you develop a set of transferable skills, such as data analysis and critical thinking that will directly meet the requirements of your current or future employer.

For further information

On this course, please visit our course webpage - http://www.cranfield.ac.uk/courses/masters/medical-technology-regulatory-affairs.html

Visit the Medical Technology Regulatory Affairs (MSc/PgDip/PgCert) page on the Cranfield University website for more details!

Entry Requirements

A first or second class UK Honours degree, or an equivalent, in a science, business or management subject, preferably with two years’ experience in a relevant role within the healthcare industry. In certain cases a blend of qualifications, motivation and relevant experience will be acceptable. Available on a part-time basis only the course is specifically designed for industry professionals working within regulatory affairs who would like to train to further their careers.

Course Fees

Home/EU - £1,500 p/a Overseas - £1,500 p/a


Email Enquiry

Recipient: Cranfield University
Insert previous message below for editing? 
You haven’t included a message. Providing a specific message means universities will take your enquiry more seriously and helps them provide the information you need.
Why not add a message here
* required field
Send a copy to me for my own records.
Email Sent

Share this page:

Cookie Policy    X