How to work in Regulatory Affairs (Drug and Medical Devices)

► Webpage: podcast.easymedicaldevice.com/21
For those that want to work on a Regulatory Affairs department, the path can be difficult. We are looking for people that are experimented but before to have experimented they should start somewhere. So how to do that.
Samantha Alsbury from TOPRA (The Organization for Professionals in Regulatory Affairs) will share with us her thoughts on this.
How long to be ready to work in Regulatory affairs?
What are the important skills to have to be a good professional?
Is the transition from one regulatory field to another difficult to do?
She will really provide us all her knowledge on this and also give us some information about TOPRA. This organization can help you to perform this transition and also to improve on your Regulatory Affairs career.
On Sept 30th to October 2nd, TOPRA is also organizing an event in Dublin where you can network with professionals. This can also be good for your career.
► Samantha Alsbury Bio
Samantha Alsbury completed her Ph.D. in Molecular Genetics at UCL in 2004, continuing with scientific research she moved into neurobiology using genetics as a tool at King’s College London before taking up a post as Senior Lecturer in Biomedical Science at the University of Greenwich. After taking on the role of Programme leader for a distance learning MSc in Biomedical Science for professional Biomedical Scientists Samantha joined The Organisation for Professionals in Regulatory Affairs (TOPRA) as the Head of Professional Development in 2016. In this role, she oversees the training, accreditation, qualifications and continuing professional development policy.
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► Links from the Video
■ Samantha Linkedin: / samantha-alsbury-76157834
■ TOPRA website: www.topra.org/
■ Twitter: / samanthaalsbury
■ Facebook Page: / topra.org
■ Linkedin Group: / 1182787
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► Social Media to follow
■ Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#regulatoryaffairs #medicaldevice #compliance

[@EasyMedicalDevice]

If you are a Regulatory Affairs Professional, you really need to listen to this. Samantha Alsbury from TOPRA is providing us with her advice on how to be a great professional. Thanks again to Samantha for her time and for the valuable information she had shared with us.

[@princetiwary3894]

One of the challenge I have felt in my experience while working in medical devices is also to know about human autonomy. This adds to the complexity because sometimes to understand the device from a design perspective it is necessary to know why design inputs work the way they do. For that a preliminary knowledge of human anatomy is needed. Especially if you have interest towards clinical or medical affairs role.

[@EasyMedicalDevice]

The solution to this is Team Work. You should not think you are alone. You should ask Marketing or sales service to explain to you. Or if you can meet a surgeon that works with a device could be great. Be curious but don‘t work alone. Autonomy is also the act of collaboration and self-education.

[@jeslinsunny]

Could you tell me more plz

[@suryaprakashsingh7039]

HELLO SIR , I am doing m.pharm in dra.. how should i approach to another courses along with these course

[@rohitgangane3867]

which is more demandable regulatory affairs or medical affairs

[@sharmisthaghosh1332]

Hello , kindly show the path as a regulatory affairs job application as a medical device, I am working in medical device company as a sales ...

[@EasyMedicalDevice]

sharmistha ghosh you may have to start with the Mini-course EU MDR 2017-745 which is free and then you can go to the Green Belt Certification program.

[@MTB_Rider_96]

can a product made up of two 510k cleared medical devices and no biologics or drugs be classified as a combination device?

[@drmiramodisvlog5203]

Hi.. can 10 yr experience cmc regulatory affairs person can understand medical device regulatory?

[@EasyMedicalDevice]

Hi Dr Mira. Not really an easy move as the regulations are completely different. But this will be easier than to start from scratch with no regulatory background

[@debasishsaha9076]

Whats the salary and how are the growth rate ?

[@arunasharma9432]

Love to know about this as I have all the background to work but never can get beyond with simple honest work ..

[@davidshaw257]

What advice, would you have for a person, who does not have an engineering or life science degree. I have a law degree and want to get into, Regulatory Affairs of Medical Devices, I also 15 years experience of production of Medical Devices.

[@EasyMedicalDevice]

I would ask this person to participate to some TOPRA trainings to get clarity on what are the regulatory requirements for devices. But what is important is experience. You should for sure try to learn but you should practice. As you have experience in Medical Device production, you also have some positive skill that can help you. Regulatory affaits foes have a huge scope and design is one if it which can help to define specifications of the product. So do not think that production is really far from regulatory affairs.

[@davidshaw257]

@@EasyMedicalDevice Thanks for your reply, I really enjoy your podcasts and as we are in lockdown in Ireland, I am watching all your podcasts as I find them very enjoyable and informative.