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The Medical Devices Regulatory Affairs Course

Is a part-time, remote and online training that runs over 3 months.

You spend a total of 6-hours per week on the lectures and the work experience / internship. You choose when to study.


We welcome students across the world, including those from the UK, USA, Canada, Europe, Switzerland, UAE, Saudi Arabia and South Africa who have or are studying for a science, engineering, IT, life science or healthcare degree or higher qualification. No previous experience is needed.


Here is what you get:

  • Work Experience / internship (3 months, part-time, homeworking, can add to your CV)

  • 50+ CPD hours of Regulatory Lectures and Assignments (EU MDR, IVDR, UK MDR, US FDA Regulations (FD&C Act, 21 CFR, 21 CFR 820), ISO 13485:2016, UDI, EUDAMED. Medical Devices Classification, Conformity Assessment, Technical Documentation, Post-Market Surveillance, Vigilance, Notified Body processes and more covered)

  • Job Search Mentoring until you get a job - mentoring, personal advice, Live job search support*

  • Expert Tutors with over 10 years of experience each — including an Honorary Associate Professor at UCL and former MHRA Agency Reviewer (GSK, MSD, Bayer) and a Medical Doctor (PhD), former Notified Body Head with expertise in MDR, ISO 13485 and MDSAP. Live Q and A sessions

  • Careers Support Training and Resources - to find jobs, apply for them and tailor CV - (AI tools for job applications, how to find secret jobs, job search tracker, templates, how to get recruiters to come to you, etc.)

  • Additional Work Experience Project (additional charge)

  • European (EU MDR, IVDR), United Kingdom and United States (FDA) Regulations Covered

  • Real World Case Studies

  • Industry Recognised Certificate — recognised by the MHRA, GSK, Lonza, Amgen and leading regulatory consultancies

  • 3 months online access - upgrade to Lifetime Access available - Course Book - additional ~£100 charge applies),

  • 1 x Expert CV Review

  • 1 x Mock Interview

  • Exclusive Regulatory Community


*In the country where you have long-term right to work (where you have a valid sponsorship/visa already)


Download the course brochure for full information



Part-time, remote course held over 3 months. 6-hours per week. You choose when to study.


Next cohort date can be found here:Few Spaces


Klarna can be used to purchase this product: Pay in 30 days or Pay in 3 instalments. Alternatively, PayPal can be used. Choose this option if needed at checkout.


If you are having any technical difficulties paying for the course, then please email contact@entrytoregulatory.com to request an invoice.


Discounted prices are available for those who are:

  • Unemployed for at least 3 months

  • In full-time education

  • NHS workers

  • Working for charities full-time

  • From low-income countries (e.g. South Africa)

  • Working in academia or government agencies

  • Multiple bookings (book with a friend or spouse)


Contact contact@entrytoregulatory.com to enquire and provide relevant evidence.


Discounts are available for multiple bookings. Moreover, in-house training is available.

Please contact contact@entrytoregulatory.com to enquire.


Returns Policy: If you change your mind at least 10 days before the course start date and before accessing the course, you will receive a full refund. If you access the digital or physical content in any way your right to refund is waived. No refund will be given if you have viewed any of the content purchased. The registration is non-transferable. Access to digital and physical content will be provided near the course start date.

Medical Devices Regulatory Affairs Course

£2,699.00 Regular Price
£1,986.00Sale Price
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