Medical Technology Regulatory Affairs MSc/PgCert/PgDip:
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.
Start Months:
The start date is flexible; you can enrol at any time throughout the year
Full Time/ Part Time: Executive/Part-time
School:
SATM
Theme:
Manufacturing
Entry Requirements:
A first or second class UK Honours degree (or equivalent) ideally in a related subject. Other recognised professional qualifications or several years relevant industrial experience may be accepted as equivalent; subject to approval by the Course Director. For further and specific information please visit the course page.
English Language:
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). Students requiring a Tier 4 (General) visa must ensure they can meet the English language requirements set out by UK Visas and Immigration (UKVI) and we recommend booking a IELTS for UKVI test.
Duration:
Part-time MSc - up to three years, Part-time PgCert - two years, Part-time PgDip - two years
Course format:
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.
Who is it for?:
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.
Students come from the UK and the EU and usually have anything from 2 - 25 years experience in the field. This mix provides excellent opportunities for networking and exchange of knowledge.
Why this course?:
This part-time course provides graduate professionals working in healthcare regulatory affairs or related areas, who have already gained first-hand practical experience of handling regulatory issues, with the opportunity to obtain a formal qualification. You will gain an advanced theoretical understanding of the processes and practices central to medical device regulatory affairs.
This formal qualification is the ideal way to demonstrate your existing skills to employers and peers, and to enhance your career in regulatory affairs by developing increasing levels of competence and professionalism, a broad view of the regulatory affairs role and provides a detailed insight into current and proposed EU legislation. It offers flexibility and support for those who wish to train whilst remaining in employment and is the gold standard in the field. Delegates gain invaluable access to industry professionals and networking events to help develop their careers. It 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.
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.
Your teaching team:
- Kamal Sehdev
- Joan Houghton
- Dr Jeff Newman
Students benefit from a programme of visiting lecturers from industry.
Course details:
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. Class sizes are kept relatively small to help create an interactive environment and to ensure each student receives excellent support from our academic team.
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.
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.
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
Assessment:
Taught modules 40%, Integrated portfolio 20%, Individual research project 40%
Core modules:
- 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
- Special Topics in Medical Devices in the EU
Funding Opportunities:
Places on this course are usually self-funded or sponsored by your company. Please contact the Enquiries Office for further information. Please note that a formal offer of a place on this course must have been received before consideration can be given for funding.
To help students find and secure appropriate funding, we have created a funding finder where you can search for suitable sources of funding by filtering the results to suit your needs.
Your career:
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.